Trial Outcomes & Findings for Rituximab and Pembrolizumab With or Without Lenalidomide in Treating Patients With Relapsed Follicular Lymphoma and Diffuse Large B-Cell Lymphoma (NCT NCT02446457)
NCT ID: NCT02446457
Last Updated: 2026-03-09
Results Overview
To determine the overall response rate (ORR) in subjects with relapsed follicular lymphoma (FL) treated with Rituximab plus pembrolizumab therapy. II. To determine the ORR in subjects with relapsed/refractory FL and relapsed/refractory diffuse large B-Cell lymphoma (DLBCL) who failed chimeric antigen receptor (CAR) T cell therapy and rea treated with rituximab in combination with pembrolizumab and lenalidomide (Cohort 2)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Approximately 1 year and 6 months
Results posted on
2026-03-09
Participant Flow
Participant milestones
| Measure |
Cohort 1
Rituxan Plus Pembrolizumab
|
Cohort 2
Rituxan Plus Pembro Plus Lenalidomide
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
14
|
|
Overall Study
COMPLETED
|
10
|
3
|
|
Overall Study
NOT COMPLETED
|
20
|
11
|
Reasons for withdrawal
| Measure |
Cohort 1
Rituxan Plus Pembrolizumab
|
Cohort 2
Rituxan Plus Pembro Plus Lenalidomide
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Relocation
|
1
|
0
|
|
Overall Study
Progression of Disease
|
13
|
7
|
Baseline Characteristics
Rituximab and Pembrolizumab With or Without Lenalidomide in Treating Patients With Relapsed Follicular Lymphoma and Diffuse Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Cohort 1
n=30 Participants
Rituxan Plus Pembrolizumab
|
Cohort 2
n=14 Participants
Rituxan Plus Pembro Plus Lenalidomide
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=68 Participants
|
12 Participants
n=69 Participants
|
42 Participants
n=137 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=68 Participants
|
5 Participants
n=69 Participants
|
18 Participants
n=137 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=68 Participants
|
9 Participants
n=69 Participants
|
26 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
3 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=68 Participants
|
12 Participants
n=69 Participants
|
41 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=68 Participants
|
11 Participants
n=69 Participants
|
40 Participants
n=137 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=68 Participants
|
14 participants
n=69 Participants
|
44 participants
n=137 Participants
|
PRIMARY outcome
Timeframe: Approximately 1 year and 6 monthsTo determine the overall response rate (ORR) in subjects with relapsed follicular lymphoma (FL) treated with Rituximab plus pembrolizumab therapy. II. To determine the ORR in subjects with relapsed/refractory FL and relapsed/refractory diffuse large B-Cell lymphoma (DLBCL) who failed chimeric antigen receptor (CAR) T cell therapy and rea treated with rituximab in combination with pembrolizumab and lenalidomide (Cohort 2)
Outcome measures
| Measure |
Cohort I (Rituximab, Pembrolizumab)
n=30 Participants
Patients receive rituximab IV over 4-8 hours on days 1, 8, 15, and 22. Patients also receive pembrolizumab IV over 1 hour on day 2 every 3 weeks for up to 16 cycles (1 year) in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Rituximab: Given IV
|
Cohort II (Rituximab, Pembrolizumab, Lenalidomide)
n=14 Participants
Patients receive rituximab IV over 4-8 hours on days 1, 8 and 15 of cycle 1, and day 1 of cycle 2. Patients also receive pembrolizumab IV over 1 hour on day 2 every 3 weeks for up to 2 years, and lenalidomide PO on days 1-14 every 3 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
Pembrolizumab: Given IV
Rituximab: Given IV
|
|---|---|---|
|
Overall Response Rate (Complete + Partial Responses)
Complete Response (CR)
|
15 Participants
|
5 Participants
|
|
Overall Response Rate (Complete + Partial Responses)
Partial Response (PR)
|
5 Participants
|
0 Participants
|
|
Overall Response Rate (Complete + Partial Responses)
Not Evaluable
|
0 Participants
|
2 Participants
|
|
Overall Response Rate (Complete + Partial Responses)
Progressive Disease (PD)
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after the completion of study treatmentWill be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Toxicity will be monitored simultaneously using the Bayesian stopping boundaries calculated based on beta-binomial distributions. Toxicity defined as any grade 3 or 4 non-hematologic toxicity that in the opinion of the principal investigator is at least possibly related to study treatment. Toxicity evaluation will be based on the incidence of severity and type of adverse events (including physical and laboratory). Frequency tables will be used to summarize categorical variables. Logistic regression will be utilized to assess the effect of patient prognostic factors on the toxicity rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 years after completion of study treatmentLogistic regression will be utilized to assess the effect of patient prognostic factors on the response rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 years after completion of study treatmentThe PFS will be compared between patients relapsing =\< 1 year vs \> 1 year after last prior therapy. The distribution of time-to-event endpoints will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 years after completion of study treatmentThe distribution of time-to-event endpoints will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.
Outcome measures
Outcome data not reported
Adverse Events
Cohort I (Rituximab, Pembrolizumab)
Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths
Cohort II (Rituximab, Pembrolizumab, Lenalidomide)
Serious events: 6 serious events
Other events: 14 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort I (Rituximab, Pembrolizumab)
n=30 participants at risk
Patients receive rituximab IV over 4-8 hours on days 1, 8, 15, and 22. Patients also receive pembrolizumab IV over 1 hour on day 2 every 3 weeks for up to 16 cycles (1 year) in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Rituximab: Given IV
|
Cohort II (Rituximab, Pembrolizumab, Lenalidomide)
n=14 participants at risk
Patients receive rituximab IV over 4-8 hours on days 1, 8 and 15 of cycle 1, and day 1 of cycle 2. Patients also receive pembrolizumab IV over 1 hour on day 2 every 3 weeks for up to 2 years, and lenalidomide PO on days 1-14 every 3 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
Pembrolizumab: Given IV
Rituximab: Given IV
|
|---|---|---|
|
Infections and infestations
Meningits
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Gastrointestinal disorders
Nausea/ Headache
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Skin and subcutaneous tissue disorders
Atrial Flutter
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Nervous system disorders
Hyperglycemia
|
3.3%
1/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Nervous system disorders
Neoplasams
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
Alainine Aminotransferase Increased
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
General disorders
Fever
|
3.3%
1/30 • Approximately 1 year and 6 months
|
14.3%
2/14 • Approximately 1 year and 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia (Neutropenia Fever)
|
0.00%
0/30 • Approximately 1 year and 6 months
|
21.4%
3/14 • Approximately 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failire
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Vascular disorders
Pulmonary Embolism
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia/ Lung Infection
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Infections and infestations
Lung Infection
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
Other adverse events
| Measure |
Cohort I (Rituximab, Pembrolizumab)
n=30 participants at risk
Patients receive rituximab IV over 4-8 hours on days 1, 8, 15, and 22. Patients also receive pembrolizumab IV over 1 hour on day 2 every 3 weeks for up to 16 cycles (1 year) in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Rituximab: Given IV
|
Cohort II (Rituximab, Pembrolizumab, Lenalidomide)
n=14 participants at risk
Patients receive rituximab IV over 4-8 hours on days 1, 8 and 15 of cycle 1, and day 1 of cycle 2. Patients also receive pembrolizumab IV over 1 hour on day 2 every 3 weeks for up to 2 years, and lenalidomide PO on days 1-14 every 3 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
Pembrolizumab: Given IV
Rituximab: Given IV
|
|---|---|---|
|
General disorders
Eye Pain
|
26.7%
8/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Approximately 1 year and 6 months
|
21.4%
3/14 • Approximately 1 year and 6 months
|
|
General disorders
Fever
|
6.7%
2/30 • Approximately 1 year and 6 months
|
14.3%
2/14 • Approximately 1 year and 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
2/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
General disorders
Eye Disorders
|
6.7%
2/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
General disorders
Blurred Vision
|
16.7%
5/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
White Blood Cound Decrease
|
10.0%
3/30 • Approximately 1 year and 6 months
|
28.6%
4/14 • Approximately 1 year and 6 months
|
|
General disorders
Edema Limbs
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
2/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
2/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
General disorders
Left Shoulder Pain
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
General disorders
Ankle Pain
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Skin and subcutaneous tissue disorders
Palpulopustialar Rash
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
Creatinine Increase
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
Decrease Total Protein
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Investigations
Sinus Bradycardia
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
General disorders
Hyponatremia
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Investigations
Alkaline Phosphatase Increase
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/30 • Approximately 1 year and 6 months
|
14.3%
2/14 • Approximately 1 year and 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Investigations
INR Increased
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
AST Increased
|
0.00%
0/30 • Approximately 1 year and 6 months
|
35.7%
5/14 • Approximately 1 year and 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
Peripheal Sensory Neuropathy
|
0.00%
0/30 • Approximately 1 year and 6 months
|
21.4%
3/14 • Approximately 1 year and 6 months
|
|
General disorders
Localized Edema
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
General disorders
Sore Throat
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
Blood Lymphatic System Disorder
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Nervous system disorders
Joint Stiffness
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
Increased TSH
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
Decreased IGG
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
General disorders
Hyperthyroidism
|
0.00%
0/30 • Approximately 1 year and 6 months
|
14.3%
2/14 • Approximately 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
2/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
General disorders
Hypocalcemia
|
0.00%
0/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
26.7%
8/30 • Approximately 1 year and 6 months
|
21.4%
3/14 • Approximately 1 year and 6 months
|
|
Gastrointestinal disorders
Liver Enzymes Abnormalaties
|
40.0%
12/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Gastrointestinal disorders
Oral Mucositis
|
10.0%
3/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.3%
7/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
Lymphocyte Count Decreased
|
33.3%
10/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Gastrointestinal disorders
Gastritis/ Esophagitis
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
6/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea/ Wheezing
|
13.3%
4/30 • Approximately 1 year and 6 months
|
28.6%
4/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
6.7%
2/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
6.7%
2/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Blood and lymphatic system disorders
White Blood Count Decrease
|
16.7%
5/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Nervous system disorders
Fatigue
|
36.7%
11/30 • Approximately 1 year and 6 months
|
14.3%
2/14 • Approximately 1 year and 6 months
|
|
Gastrointestinal disorders
Nausea/ Vomitting
|
3.3%
1/30 • Approximately 1 year and 6 months
|
28.6%
4/14 • Approximately 1 year and 6 months
|
|
Infections and infestations
Menugitis
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Vascular disorders
Hypertension
|
10.0%
3/30 • Approximately 1 year and 6 months
|
7.1%
1/14 • Approximately 1 year and 6 months
|
|
General disorders
Infusion Related Reaction
|
6.7%
2/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
General disorders
Watering Eyes
|
26.7%
8/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
General disorders
Irritated Eyes
|
3.3%
1/30 • Approximately 1 year and 6 months
|
0.00%
0/14 • Approximately 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
6/30 • Approximately 1 year and 6 months
|
14.3%
2/14 • Approximately 1 year and 6 months
|
Additional Information
Ranjit Nair, MD
The University of Texas MD Anderson Cancer Center
Phone: (281) 787-7904
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place