Trial Outcomes & Findings for Lenalidomide, Ixazomib, and Rituximab as Front-Line Therapy for High Risk Indolent B-Cell Lymphoma (NCT NCT02898259)
NCT ID: NCT02898259
Last Updated: 2022-09-26
Results Overview
To determine the MTD of the combination of oral ixazomib and lenalidomide plus rituximab in patients with previously untreated low-grade B cell lymphoma having high tumor burden by GELF criteria or FLIPI 3-5. MTD will be determined using the first 12 participants 15 months after beginning treatment
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
15 months after beginning treatment
Results posted on
2022-09-26
Participant Flow
Participant milestones
| Measure |
DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort I: Follicular Lymphoma at MTD
Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort 2: Non-Follicular Lymphoma at MTD
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
7
|
0
|
|
Overall Study
COMPLETED
|
2
|
2
|
1
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
5
|
1
|
0
|
Reasons for withdrawal
| Measure |
DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort I: Follicular Lymphoma at MTD
Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort 2: Non-Follicular Lymphoma at MTD
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
3
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Transformation before study began
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Lenalidomide, Ixazomib, and Rituximab as Front-Line Therapy for High Risk Indolent B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=6 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort 1: Follicular Lymphoma at MTD
n=7 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort 2: Non-Follicular Lymphoma at MTD
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
80-89 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
|
Age, Customized
40-49 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Age, Customized
50-59 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
|
Age, Customized
60-69 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
|
Age, Customized
70-79 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
19 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
18 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
7 participants
n=7 Participants
|
—
|
19 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 15 months after beginning treatmentPopulation: First 12 participants put on study
To determine the MTD of the combination of oral ixazomib and lenalidomide plus rituximab in patients with previously untreated low-grade B cell lymphoma having high tumor burden by GELF criteria or FLIPI 3-5. MTD will be determined using the first 12 participants 15 months after beginning treatment
Outcome measures
| Measure |
Lenalidomide + Ixazomib + Rituximab
n=12 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort I: Follicular Lymphoma at MTD
Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort 2: Non-Follicular Lymphoma at MTD
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Oral Ixazomib
|
4 mg
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 15 months after beginning treatmentPopulation: Participants who received treatment
These criteria are based on the Revised Response Criteria for Malignant Lymphoma and include the following categories: Complete Response (CR)(Complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy), Partial Response (PR) (A ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses), Stable Disease (SD) (Failing to attain the criteria needed for a PR or CR, but not fulfilling those for progressive disease), Relapse and Progression (PD) (For determination of relapsed and progressive disease, lymph nodes should be considered abnormal if the long axis is more than 1.5 cm, regardless of the short axis).
Outcome measures
| Measure |
Lenalidomide + Ixazomib + Rituximab
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=6 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort I: Follicular Lymphoma at MTD
n=6 Participants
Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort 2: Non-Follicular Lymphoma at MTD
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
|---|---|---|---|---|---|
|
Overall Response Rate
Complete response
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Overall Response Rate
Stable Disease
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Overall Response Rate
Partial Response
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Overall Response Rate
Relapse and Progression
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 15 months after beginning treatmentPopulation: Participants who received treatment
Duration of overall response: The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.
Outcome measures
| Measure |
Lenalidomide + Ixazomib + Rituximab
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=6 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort I: Follicular Lymphoma at MTD
n=6 Participants
Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort 2: Non-Follicular Lymphoma at MTD
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
|---|---|---|---|---|---|
|
Duration of Response
|
2.7 months
Interval 2.7 to 2.7
|
8.9 months
Interval 2.7 to 15.0
|
5.5 months
Interval 2.7 to 12.2
|
8.7 months
Interval 2.8 to 12.9
|
—
|
SECONDARY outcome
Timeframe: Up to 15 months after beginning treatmentPopulation: Participants who received treatment
Duration of time from start of treatment to time of progression.
Outcome measures
| Measure |
Lenalidomide + Ixazomib + Rituximab
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=6 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort I: Follicular Lymphoma at MTD
n=6 Participants
Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort 2: Non-Follicular Lymphoma at MTD
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
|---|---|---|---|---|---|
|
Time to Progression
|
0 months
Interval 0.0 to 0.0
|
2.5 months
Interval 2.5 to 2.5
|
9.0 months
Interval 9.0 to 9.0
|
4.6 months
Interval 4.6 to 4.6
|
—
|
SECONDARY outcome
Timeframe: Up to 15 months after beginning treatmentPopulation: Participants who received treatment
A number of participants who survived without disease progression PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Lenalidomide + Ixazomib + Rituximab
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=6 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort I: Follicular Lymphoma at MTD
n=6 Participants
Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort 2: Non-Follicular Lymphoma at MTD
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
|---|---|---|---|---|---|
|
Progression Free Survival
|
3 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 15 months after beginning treatmentPopulation: Participants who received treatment
Time to treatment failure (event-free survival) is defined as the time from study entry to first event of disease progression, discontinuation of treatment for any reason, initiation of new treatment, or death.
Outcome measures
| Measure |
Lenalidomide + Ixazomib + Rituximab
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=6 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort I: Follicular Lymphoma at MTD
n=6 Participants
Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort 2: Non-Follicular Lymphoma at MTD
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
|---|---|---|---|---|---|
|
Time to Treatment Failure
|
10 months
Interval 10.0 to 10.0
|
0 months
Interval 0.0 to 0.0
|
6.1 months
Interval 2.7 to 14.5
|
5.8 months
Interval 5.8 to 5.8
|
—
|
SECONDARY outcome
Timeframe: Up to 15 months after beginning treatmentPopulation: Participants who received treatment
Overall survival is defined as the date of study entry to the date of death.
Outcome measures
| Measure |
Lenalidomide + Ixazomib + Rituximab
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=3 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=6 Participants
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort I: Follicular Lymphoma at MTD
n=6 Participants
Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort 2: Non-Follicular Lymphoma at MTD
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
|---|---|---|---|---|---|
|
Overall Survival
|
3 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
Adverse Events
DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Expansion Cohort I: Follicular Lymphoma at MTD
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Expansion Cohort 2: Non-Follicular Lymphoma at MTD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=3 participants at risk
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=3 participants at risk
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=6 participants at risk
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort I: Follicular Lymphoma at MTD
n=6 participants at risk
Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration
|
Expansion Cohort 2: Non-Follicular Lymphoma at MTD
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection- Pneumonia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Vascular disorders
Thromboembolic event
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Renal and urinary disorders
Acute renal insufficiency
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
Other adverse events
| Measure |
DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=3 participants at risk
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=3 participants at risk
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)
n=6 participants at risk
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
Expansion Cohort I: Follicular Lymphoma at MTD
n=6 participants at risk
Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration
|
Expansion Cohort 2: Non-Follicular Lymphoma at MTD
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
General disorders
Chills
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
General disorders
Fatigue
|
66.7%
2/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Infections and infestations
Upper Respiratory Infection
|
66.7%
2/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
66.7%
2/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Infections and infestations
Pleuritic Pain
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
66.7%
2/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
66.7%
2/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
83.3%
5/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Skin and subcutaneous tissue disorders
Indeterminate skin eruptions
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
50.0%
3/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Skin and subcutaneous tissue disorders
Itchy scalp
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
66.7%
2/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
83.3%
5/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
83.3%
5/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
83.3%
5/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Gastrointestinal disorders
Abdominal Cramping
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
66.7%
4/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Infections and infestations
Alkaline phosphatase increased
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Infections and infestations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Infections and infestations
MRSA skin infection
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Infections and infestations
Legionella pneumonia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Vascular disorders
Thromboembolic event
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Vascular disorders
Superficial Thrombophlebitis
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Vascular disorders
Edema
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
50.0%
3/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
66.7%
2/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Nervous system disorders
Radiculitis
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Blood and lymphatic system disorders
Petechiae
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
50.0%
3/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
50.0%
3/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Investigations
Hypernatremia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Investigations
Hypokalemia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Musculoskeletal and connective tissue disorders
Upper arm pain
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Musculoskeletal and connective tissue disorders
Wrist pain
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
50.0%
3/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Cardiac disorders
Chest pain- cardiac
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Eye disorders
Blurred vision
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
33.3%
2/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/3 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
16.7%
1/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
0.00%
0/6 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
—
0/0 • Up to 5 years
1 participant in arm "Expansion Cohort I: Follicular Lymphoma at MTD" was taken off study before treatment because of transofrmation and was therefore not followed for adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place