Trial Outcomes & Findings for BV-CHEP Chemotherapy for Adult T-cell Leukemia or Lymphoma (NCT NCT03264131)
NCT ID: NCT03264131
Last Updated: 2026-07-29
Results Overview
The response was assessed based on the International Workshop to standardize response criteria for malignant lymphomas (i.e., Lugano Criteria per Cheson, et al. J Clin Oncol. 2014;32(27):3059-68; Complete Response: Positron emission tomography (PET): Complete metabolic response Computerized tomography (CT): Target must regress to ≤ 1.5 cm in the largest transverse diameter (LDi) or no extra lymphatic sites of disease. Partial Response: PET: reduced uptake compared with baseline, and CT: ≥50% decrease in the sum of the products of diameters (SPD).No Response or Stable Disease: No metabolic response on PET or \< 50% decrease from baseline in SPD of up to 6 dominant, measurable nodes and extra nodal sites on CT. Progressive Disease: PET: Score 4 or 5 with an increase in the intensity of uptake or CT: an individual node/lesion must be abnormal with LDi \> 1.5 cm, increase by ≥ 50% from the cross product of the LDi and shortest axis perpendicular to LDi (SDi).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
18 weeks
Results posted on
2026-07-29
Participant Flow
Participants were enrolled in the study between 10/11/2018 - 06/22/2022 at four cancer centers in the United States.
A total of sixteen eligible participants consented and started to the study.
Participant milestones
| Measure |
Open-label, Multicenter, Single-Arm
This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death.
Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles
Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles.
Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles.
Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BV-CHEP Chemotherapy for Adult T-cell Leukemia or Lymphoma
Baseline characteristics by cohort
| Measure |
Open-label, Multicenter, Single-Arm
n=16 Participants
This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death.
Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles
Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles.
Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles.
Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
|
|---|---|
|
Age, Continuous
|
56 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: Participants started the study and response assessments were completed.
The response was assessed based on the International Workshop to standardize response criteria for malignant lymphomas (i.e., Lugano Criteria per Cheson, et al. J Clin Oncol. 2014;32(27):3059-68; Complete Response: Positron emission tomography (PET): Complete metabolic response Computerized tomography (CT): Target must regress to ≤ 1.5 cm in the largest transverse diameter (LDi) or no extra lymphatic sites of disease. Partial Response: PET: reduced uptake compared with baseline, and CT: ≥50% decrease in the sum of the products of diameters (SPD).No Response or Stable Disease: No metabolic response on PET or \< 50% decrease from baseline in SPD of up to 6 dominant, measurable nodes and extra nodal sites on CT. Progressive Disease: PET: Score 4 or 5 with an increase in the intensity of uptake or CT: an individual node/lesion must be abnormal with LDi \> 1.5 cm, increase by ≥ 50% from the cross product of the LDi and shortest axis perpendicular to LDi (SDi).
Outcome measures
| Measure |
Open-label, Multicenter, Single-Arm
n=16 Participants
This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death.
Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles
Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles.
Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles.
Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
|
|---|---|
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Complete Response Rate After 2-6 Cycles of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (BV-CHEP)
Progressive Disease
|
2 Participants
|
|
Complete Response Rate After 2-6 Cycles of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (BV-CHEP)
Complete Response
|
10 Participants
|
|
Complete Response Rate After 2-6 Cycles of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (BV-CHEP)
Partial Response
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsORR will be evaluated as the rate of complete responses (CR) + partial responses (PR) as defined by the International Workshop to standardize response criteria for malignant lymphomas (i.e. Lugano Criteria). Patients with leukemic component to their disease at baseline will be assessed per Adult T-Cell Leukemia/Lymphoma National Comprehensive Cancer Network (NCCN) guidelines version 2.2017
Outcome measures
| Measure |
Open-label, Multicenter, Single-Arm
n=16 Participants
This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death.
Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles
Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles.
Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles.
Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
|
|---|---|
|
Overall Response Rate (ORR) Associated With 2-6 Cycles of BV-CHEP Therapy in Patients With Adult T-Cell Leukemia/Lymphoma.
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 15.2 monthsPFS is assessed from day 1 of treatment until disease progression (based on International Workshop to standardize response criteria for malignant lymphomas (i.e. Lugano Criteria) or death. Progression Free Survival (PFS) is calculated from the date of randomization to the date of progression or the date of death from any cause. The median PFS is estimated using the Kaplan-Meier method. The Measure of Dispersion reported is the Full Range, representing the minimum and maximum observed follow-up time (whether censored or event occurred) for all participants in this group.
Outcome measures
| Measure |
Open-label, Multicenter, Single-Arm
n=16 Participants
This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death.
Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles
Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles.
Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles.
Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
|
|---|---|
|
Progression-free Survival (PFS) for BV-CHEP in Patients With Adult T-cell Leukemia/Lymphoma
|
7.11 months
Interval 0.7 to 15.2
|
SECONDARY outcome
Timeframe: Up to 24 monthsDuration of response is defined as the time from documentation of tumor response per Lugano criteria to disease progression. Subjects with a leukemic component to their disease at baseline will have peripheral blood assessed per adult T-cell leukemia/lymphoma NCCN Guidelines version 2.2017
Outcome measures
| Measure |
Open-label, Multicenter, Single-Arm
n=10 Participants
This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death.
Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles
Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles.
Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles.
Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
|
|---|---|
|
Duration of Response to BV-CHEP in Patients With Adult T-cell Leukemia/Lymphoma
|
3.84 months
Interval 0.76 to 12.46
|
SECONDARY outcome
Timeframe: Up to 68 monthsOverall survival is defined as the time from date of randomization until death from any cause. The median OS is estimated using the Kaplan-Meier method. The Measure of Dispersion reported is the Full Range, representing the minimum and maximum observed follow-up time (whether censored or event occurred) for all participants in this group. BV maintenance was not reported because only one patient received it, and only for a limited number of dose.
Outcome measures
| Measure |
Open-label, Multicenter, Single-Arm
n=16 Participants
This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death.
Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles
Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles.
Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles.
Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
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|---|---|
|
Overall Survival (OS) of Patients With Adult T-cell Leukemia/Lymphoma Treated With BV-CHEP Who Received or Did Not Receive BV Maintenance Therapy.
|
15.7 months
Interval 3.3 to 68.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsToxicity and tolerability of therapy will be assessed via the NCI CTCAE v4.03, a scale from 1-mild to 5-death.Only treatment-attributed Grade ≥3 adverse events were included.
Outcome measures
| Measure |
Open-label, Multicenter, Single-Arm
n=16 Participants
This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death.
Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles
Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles.
Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles.
Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
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|---|---|
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BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Mucositis oral
|
3 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Nausea
|
1 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Typhlitis
|
1 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Vomiting
|
1 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
colitis
|
1 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Lymphocyte count decreased
|
3 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Neutrophil count decreased
|
5 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Platelet count decreased
|
4 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
White blood cell decreased
|
5 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Hypokalemia
|
1 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Hyponatremia
|
1 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Dyspnea
|
1 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Anemia
|
7 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Febrile neutropenia
|
6 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Abdominal pain
|
1 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Esophagitis
|
1 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Sore throat
|
1 Participants
|
|
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Hypotension
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 309Population: Participants received BV maintenance was included.
PFS will be measured from day 1 of treatment to disease progression (per the Lugano Criteria) or death. BV maintenance was minimal, with only one patient receiving a limited number of doses. The single analyzed participant experienced disease progression during the study period. Number of participant showed no progression is reported.
Outcome measures
| Measure |
Open-label, Multicenter, Single-Arm
n=1 Participants
This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death.
Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles
Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles.
Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles.
Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
|
|---|---|
|
Progression-free Survival (PFS) for BV Maintenance
|
0 Participants
|
Adverse Events
Open-label, Multicenter, Single-Arm
Serious events: 7 serious events
Other events: 9 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Open-label, Multicenter, Single-Arm
n=16 participants at risk
This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death.
Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles
Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles.
Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles.
Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
|
|---|---|
|
Investigations
Weight loss
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Ear and labyrinth disorders
Hearing impaired
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Eye disorders
Eye pain
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Mucositis oral
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Typhlitis
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
General disorders
Fever
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
General disorders
pain
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Investigations
Neutrophil count decreased
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Investigations
Platelet count decreased
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
Other adverse events
| Measure |
Open-label, Multicenter, Single-Arm
n=16 participants at risk
This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death.
Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles
Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles.
Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles.
Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
|
|---|---|
|
Eye disorders
Eye disorders - Other, specify
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Abdominal pain
|
31.2%
5/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Colitis
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Diarrhea
|
31.2%
5/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Mucositis oral
|
37.5%
6/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Nausea
|
43.8%
7/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
General disorders
Chills
|
37.5%
6/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
General disorders
Edema limbs
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
General disorders
Fatigue
|
25.0%
4/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
General disorders
Fever
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Blood and lymphatic system disorders
Anemia
|
43.8%
7/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
18.8%
3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
18.8%
3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Infections and infestations
Upper respiratory infection
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Investigations
Cholesterol high
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Investigations
Creatinine increased
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Investigations
Investigations - Other, specify
|
25.0%
4/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Investigations
Lymphocyte count decreased
|
18.8%
3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Investigations
Lymphocyte count increased
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Investigations
Neutrophil count decreased
|
25.0%
4/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Investigations
Platelet count decreased
|
25.0%
4/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Investigations
White blood cell decreased
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.8%
3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.8%
3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
4/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
18.8%
3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Nervous system disorders
Dizziness
|
31.2%
5/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Nervous system disorders
Headache
|
37.5%
6/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Nervous system disorders
Paresthesia
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Nervous system disorders
Radiculitis
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Nervous system disorders
Tremor
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Psychiatric disorders
Anxiety
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Psychiatric disorders
Insomnia
|
18.8%
3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Renal and urinary disorders
Cystitis noninfective
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
18.8%
3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
18.8%
3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Vascular disorders
Hypertension
|
12.5%
2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
|
Additional Information
Melahat Garipagaoglu Canter
UNC Lineberger Comprehensive Cancer Center
Phone: 919-962-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Study publication should be a joint publication of all sites. A separate site publication is restricted until 24 months after the study completion or study publication.
- Publication restrictions are in place
Restriction type: OTHER