Trial Outcomes & Findings for Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide (NCT NCT01458366)
NCT ID: NCT01458366
Last Updated: 2025-04-30
Results Overview
To determine the maximum-tolerated dose of bendamustine in combination with ofatumumab, carboplatin and etoposide for patients with refractory or relapsed aggressive B cell lymphomas. Toxicity levels will be assessed after every cycle until a dose-limiting toxicity (DLT) is found. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria (CTCAE version 4.0). DLT will be defined as any grade 4 infection, or grade \>/= 3 non-hematologic toxicity that persists for 7 days or more.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Baseline through 50 days
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
Bendamustine 70mg/m^2
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine:
\- Level 1: 70 mg/m2
|
Bendamustine 50mg/m^2
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine:
\- Level -1: 50 mg/m2
|
Bendamustin 90mg/m^2
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine:
\- Level 2: 90 mg/m2
|
Bendamustine 120mg/m^2
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine:
\- Level 3: 120 mg/m\^2
|
Bendamustine at MTD
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine:
Phase II at the MTD
|
|---|---|---|---|---|---|
|
Period 1: 70mg/m^2
STARTED
|
5
|
0
|
0
|
0
|
0
|
|
Period 1: 70mg/m^2
COMPLETED
|
3
|
0
|
0
|
0
|
0
|
|
Period 1: 70mg/m^2
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
|
Period 2: 50mg/m^2
STARTED
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: 50mg/m^2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: 50mg/m^2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 3: 90mg/m^2
STARTED
|
0
|
0
|
3
|
0
|
0
|
|
Period 3: 90mg/m^2
COMPLETED
|
0
|
0
|
3
|
0
|
0
|
|
Period 3: 90mg/m^2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 4: 120mg/m^2
STARTED
|
0
|
0
|
0
|
3
|
0
|
|
Period 4: 120mg/m^2
COMPLETED
|
0
|
0
|
0
|
3
|
0
|
|
Period 4: 120mg/m^2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 5: Maximum Tolerated Dose (MTD)
STARTED
|
0
|
0
|
0
|
0
|
27
|
|
Period 5: Maximum Tolerated Dose (MTD)
COMPLETED
|
0
|
0
|
0
|
0
|
26
|
|
Period 5: Maximum Tolerated Dose (MTD)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Bendamustine 70mg/m^2
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine:
\- Level 1: 70 mg/m2
|
Bendamustine 50mg/m^2
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine:
\- Level -1: 50 mg/m2
|
Bendamustin 90mg/m^2
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine:
\- Level 2: 90 mg/m2
|
Bendamustine 120mg/m^2
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine:
\- Level 3: 120 mg/m\^2
|
Bendamustine at MTD
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine:
Phase II at the MTD
|
|---|---|---|---|---|---|
|
Period 1: 70mg/m^2
Physician Decision
|
2
|
0
|
0
|
0
|
0
|
|
Period 5: Maximum Tolerated Dose (MTD)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide
Baseline characteristics by cohort
| Measure |
Bendamustine 70 mg/m2
n=5 Participants
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
\- Level 1: 70 mg/m2
|
Bendamustine 50 mg/m2
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
\- Level -1: 50 mg/m2
|
Bendamustine 90 mg/m2
n=3 Participants
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
\- Level 2: 90 mg/m2
|
Bendamustine 120 mg/m2
n=3 Participants
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
\- Level 3: 120 mg/m2
|
Bendamustine at MTD
n=27 Participants
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.
Ofatumumab: Phase II
* Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3
* Cycles 2 and 3: 1000 mg via IV on Day 1
Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle
Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
37 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
—
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
27 participants
n=21 Participants
|
36 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through 50 daysPopulation: Patients enrolled on the Phase 1 portion of the study
To determine the maximum-tolerated dose of bendamustine in combination with ofatumumab, carboplatin and etoposide for patients with refractory or relapsed aggressive B cell lymphomas. Toxicity levels will be assessed after every cycle until a dose-limiting toxicity (DLT) is found. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria (CTCAE version 4.0). DLT will be defined as any grade 4 infection, or grade \>/= 3 non-hematologic toxicity that persists for 7 days or more.
Outcome measures
| Measure |
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)
n=11 Participants
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
* Level 1: 70 mg/m2
* Level -1: 50 mg/m2
* Level 2: 90 mg/m2
* Level 3: 120 mg/m2
Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.
Ofatumumab: Phase II
* Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3
* Cycles 2 and 3: 1000 mg via IV on Day 1
Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle
Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
|
|---|---|
|
Phase I: Maximum-Tolerated Dose of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide (BOCE)
|
120 mg/m^2
|
PRIMARY outcome
Timeframe: At 25 days and 3-8 weeks post-treatmentPopulation: Patients who received MTD in phase 1 and the phase 2 patients were evaluated in combined analysis.
To determine the overall frequency of response with combination bendamustine, ofatumumab, carboplatin, and etoposide for refractory or relapsed aggressive B-cell lymphomas. Overall response is determined as cumulative Complete Response (CR) and Partial Response (PR).
Outcome measures
| Measure |
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)
n=28 Participants
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
* Level 1: 70 mg/m2
* Level -1: 50 mg/m2
* Level 2: 90 mg/m2
* Level 3: 120 mg/m2
Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.
Ofatumumab: Phase II
* Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3
* Cycles 2 and 3: 1000 mg via IV on Day 1
Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle
Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
|
|---|---|
|
Overall Frequency of Response With Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide at Maximum Tolerated Dose (MTD)
|
20 Participants
|
SECONDARY outcome
Timeframe: CT and PET scans after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatmentPopulation: For the Phase 1 analysis, participants who received doses of Bendamustine below the MTD were combined for the statistical analysis.
To determine the overall frequency of response--overall response will include all subjects with complete response (CR) and partial response (PR). Based on the revised response criteria for malignant lymphoma \[Cheson 2007\] CR= complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy PR= \>/= 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of other nodes, liver or spleen;
Outcome measures
| Measure |
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)
n=11 Participants
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
* Level 1: 70 mg/m2
* Level -1: 50 mg/m2
* Level 2: 90 mg/m2
* Level 3: 120 mg/m2
Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.
Ofatumumab: Phase II
* Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3
* Cycles 2 and 3: 1000 mg via IV on Day 1
Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle
Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
|
|---|---|
|
Phase I: Overall Frequency of Response
|
7 Participants
|
SECONDARY outcome
Timeframe: CT and PET scans after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatmentPopulation: one subject withdrew voluntarily and was not analyzed. The patients enrolled into Phase I portion were combined into one analysis group to compare the two phases of the study.
Based on the revised response criteria for malignant lymphoma \[Cheson 2007\] CR= complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy PR= \>/= 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of other nodes, liver or spleen;
Outcome measures
| Measure |
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)
n=35 Participants
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
* Level 1: 70 mg/m2
* Level -1: 50 mg/m2
* Level 2: 90 mg/m2
* Level 3: 120 mg/m2
Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.
Ofatumumab: Phase II
* Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3
* Cycles 2 and 3: 1000 mg via IV on Day 1
Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle
Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
|
|---|---|
|
Overall Complete Response (CR) and Partial Response (PR) Rate
Phase 2 · Complete Response
|
12 Participants
|
|
Overall Complete Response (CR) and Partial Response (PR) Rate
Phase 2 · Partial Response
|
4 Participants
|
|
Overall Complete Response (CR) and Partial Response (PR) Rate
Phase 2 · No response
|
8 Participants
|
|
Overall Complete Response (CR) and Partial Response (PR) Rate
Phase 1 · Complete Response
|
5 Participants
|
|
Overall Complete Response (CR) and Partial Response (PR) Rate
Phase 1 · Partial Response
|
3 Participants
|
|
Overall Complete Response (CR) and Partial Response (PR) Rate
Phase 1 · No response
|
3 Participants
|
SECONDARY outcome
Timeframe: At 1 and 2 years after completion of treatment; year 2 reportedPopulation: Patients who achieved a complete or partial response. median progression free survival was not achieved in patients undergoing transplant. This population is patients who received the Maximum Tolerated Dose in both Phase I and Phase II. One patient withdrew and was not included in the analysis.
To determine 1 and 2 year progression-free survival \[Cheson 2007\] CR= complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy PR= \>/= 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of other nodes, liver or spleen;
Outcome measures
| Measure |
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)
n=28 Participants
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
* Level 1: 70 mg/m2
* Level -1: 50 mg/m2
* Level 2: 90 mg/m2
* Level 3: 120 mg/m2
Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.
Ofatumumab: Phase II
* Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3
* Cycles 2 and 3: 1000 mg via IV on Day 1
Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle
Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
|
|---|---|
|
Overall Progression-Free Survival
|
5.1 months
Interval 4.0 to
Not enough participants achieved response to calculate upper 95% CI
|
SECONDARY outcome
Timeframe: At 1 and 2 years after completion of treatment; year 2 reportedPopulation: One patient withdrew and was not included in the analysis. For the purpose of this analysis, patients in both phases were combined into two groups based on whether or not the patient received a transplant.
1 and 2 year overall survival for those who received Stem Cell Transplant (SCT) versus those who did not receive SCT
Outcome measures
| Measure |
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)
n=35 Participants
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
* Level 1: 70 mg/m2
* Level -1: 50 mg/m2
* Level 2: 90 mg/m2
* Level 3: 120 mg/m2
Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.
Ofatumumab: Phase II
* Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3
* Cycles 2 and 3: 1000 mg via IV on Day 1
Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle
Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
|
|---|---|
|
Total Overall Survival for Transplant vs Non-transplant
Did not receive transplant
|
7.4 months
Interval 5.7 to
Not enough participants achieved response to calculate upper 95% CI
|
|
Total Overall Survival for Transplant vs Non-transplant
Received transplant
|
27.3 months
Interval 26.6 to
Not enough participants achieved response to calculate upper 95% CI
|
SECONDARY outcome
Timeframe: At 2 years after completion of treatmentPopulation: one subject withdrew voluntarily and was not analyzed. patients from both Phase I and Phase II were analyzed cumulatively for the purpose of analyzing the patients who received a transplant
To determine the proportion of patients who are able to undergo stem cell transplant among transplant-eligible patients. Patients can receive SCT after Cycle 2.
Outcome measures
| Measure |
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)
n=35 Participants
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
* Level 1: 70 mg/m2
* Level -1: 50 mg/m2
* Level 2: 90 mg/m2
* Level 3: 120 mg/m2
Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.
Ofatumumab: Phase II
* Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3
* Cycles 2 and 3: 1000 mg via IV on Day 1
Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle
Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
|
|---|---|
|
Overall Proportion of Patients Who Are Able to Undergo Stem Cell Transplant (SCT)
|
12 Participants
|
SECONDARY outcome
Timeframe: After each cycle (after approximately 3 days, 25 days, and 50 days)Population: one subject withdrew voluntarily and was not analyzed. As no dose modifications were needed during the study, results of analysis are provided based on the overall patients enrolled to the study.
To define safety and tolerability of the combination of ofatumumab, bendamustine, carboplatin and etoposide as measured by the number of dose modifications made to Bendamustine.. Determined through dose modifications for bendamustine according to patient's toxicity levels: * Initial 120 mg/m2 dose decreased to 90 mg/m2 * Initial 90 mg/m2 dose decreased to 70 mg/m2 * Initial 70 mg/m2 dose decreased to 50 mg/m2 * Initial 50 mg/m2 dose decreased to Withdrawn from study
Outcome measures
| Measure |
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)
n=35 Participants
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
* Level 1: 70 mg/m2
* Level -1: 50 mg/m2
* Level 2: 90 mg/m2
* Level 3: 120 mg/m2
Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.
Ofatumumab: Phase II
* Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3
* Cycles 2 and 3: 1000 mg via IV on Day 1
Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle
Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
|
|---|---|
|
Overall Safety and Tolerability of the Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
|
0 dose modifications
|
Adverse Events
Bendamustine 70 mg/m2
Serious events: 4 serious events
Other events: 3 other events
Deaths: 4 deaths
Bendamustine 50 mg/m2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bendamustine 90 mg/m2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Bendamustine 120 mg/m2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Bendamustine at MTD
Serious events: 11 serious events
Other events: 11 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Bendamustine 70 mg/m2
n=5 participants at risk
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
\- Level 1: 70 mg/m2
|
Bendamustine 50 mg/m2
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
\- Level -1: 50 mg/m2
|
Bendamustine 90 mg/m2
n=3 participants at risk
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
\- Level 2: 90 mg/m2
|
Bendamustine 120 mg/m2
n=3 participants at risk
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
\- Level 3: 120 mg/m2
|
Bendamustine at MTD
n=27 participants at risk
Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.
Ofatumumab: Phase II
* Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3
* Cycles 2 and 3: 1000 mg via IV on Day 1
Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle
Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
40.0%
2/5 • Number of events 3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
33.3%
1/3 • Number of events 1 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
14.8%
4/27 • Number of events 5 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
40.0%
2/5 • Number of events 11 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
66.7%
2/3 • Number of events 13 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
100.0%
3/3 • Number of events 18 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
29.6%
8/27 • Number of events 10 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Blood and lymphatic system disorders
thromboembolic event
|
20.0%
1/5 • Number of events 1 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/27 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
11.1%
3/27 • Number of events 3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
20.0%
1/5 • Number of events 8 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
7.4%
2/27 • Number of events 2 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
0.00%
0/5 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
33.3%
1/3 • Number of events 1 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/27 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Blood and lymphatic system disorders
Hyperurecemia
|
0.00%
0/5 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
3.7%
1/27 • Number of events 11 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Number of events 1 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
7.4%
2/27 • Number of events 2 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Hepatobiliary disorders
Increase Bilirubin
|
0.00%
0/5 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
3.7%
1/27 • Number of events 1 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
3.7%
1/27 • Number of events 1 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
3/5 • Number of events 5 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
66.7%
2/3 • Number of events 5 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
100.0%
3/3 • Number of events 10 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
11.1%
3/27 • Number of events 3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Hepatobiliary disorders
Decreased ANC
|
60.0%
3/5 • Number of events 5 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
33.3%
1/3 • Number of events 6 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
100.0%
3/3 • Number of events 7 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
29.6%
8/27 • Number of events 10 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
20.0%
1/5 • Number of events 1 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
3.7%
1/27 • Number of events 1 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Hepatobiliary disorders
Increased AST
|
0.00%
0/5 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
3.7%
1/27 • Number of events 1 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
0.00%
0/5 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
33.3%
1/3 • Number of events 2 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
3.7%
1/27 • Number of events 1 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Blood and lymphatic system disorders
Decreased ALC
|
0.00%
0/5 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
100.0%
3/3 • Number of events 17 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
22.2%
6/27 • Number of events 8 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
General disorders
Tumor Lysis Syndrome
|
0.00%
0/5 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
0.00%
0/3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
3.7%
1/27 • Number of events 1 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
Blood and lymphatic system disorders
Decreased White Blood Cell Count
|
80.0%
4/5 • Number of events 14 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
100.0%
3/3 • Number of events 7 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
100.0%
3/3 • Number of events 12 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
14.8%
4/27 • Number of events 6 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
Other adverse events
| Measure |
Bendamustine 70 mg/m2
n=5 participants at risk
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
\- Level 1: 70 mg/m2
|
Bendamustine 50 mg/m2
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
\- Level -1: 50 mg/m2
|
Bendamustine 90 mg/m2
n=3 participants at risk
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
\- Level 2: 90 mg/m2
|
Bendamustine 120 mg/m2
n=3 participants at risk
Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Bendamustine: Phase 1: Given via IV at the following dose levels:
\- Level 3: 120 mg/m2
|
Bendamustine at MTD
n=27 participants at risk
Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.
Ofatumumab: Phase II
* Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3
* Cycles 2 and 3: 1000 mg via IV on Day 1
Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle
Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
3/5 • Number of events 23 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
66.7%
2/3 • Number of events 17 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
100.0%
3/3 • Number of events 13 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
40.7%
11/27 • Number of events 17 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
|
General disorders
Fatigue
|
60.0%
3/5 • Number of events 3 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
—
0/0 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
66.7%
2/3 • Number of events 2 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
66.7%
2/3 • Number of events 2 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
40.7%
11/27 • Number of events 11 • 2 years from baseline
adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
|
Additional Information
Joanna Filicko-O'Hara, MD
Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215-503-7787
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place