Trial Outcomes & Findings for Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma (NCT NCT01165112)
NCT ID: NCT01165112
Last Updated: 2018-12-05
Results Overview
Defined as dose at which approximately =\< 25% of patients experience a DLT. Following completed observation of final patient, two-parameter logistic model fit to data, generating dose-response curve based on observed toxicity rate at dose levels visited. Based on this fitted model, MTD is estimated to be dose that is associated with toxicity rate of 25%. If estimate of slope parameter for fitted curve is not positive and finite, geometric mean of dose level used for last cohort and dose level that would have been assigned to next cohort is taken as MTD.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Up to 5 weeks after the last course
Results posted on
2018-12-05
Participant Flow
Participant milestones
| Measure |
Treatment (Chemotherapy and Monoclonal Antibody Therapy)
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy and Monoclonal Antibody Therapy)
n=48 Participants
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
56 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 5 weeks after the last courseDefined as dose at which approximately =\< 25% of patients experience a DLT. Following completed observation of final patient, two-parameter logistic model fit to data, generating dose-response curve based on observed toxicity rate at dose levels visited. Based on this fitted model, MTD is estimated to be dose that is associated with toxicity rate of 25%. If estimate of slope parameter for fitted curve is not positive and finite, geometric mean of dose level used for last cohort and dose level that would have been assigned to next cohort is taken as MTD.
Outcome measures
| Measure |
Treatment (Chemotherapy and Monoclonal Antibody Therapy)
n=48 Participants
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Maximally Tolerated Dose of Bendamustine Hydrochloride That Can be Combined With Rituximab, Carboplatin, and Etoposide Chemotherapy in Patients With Relapsed or Refractory Lymphoid Malignancies
|
120 mg/m2 x 2
|
PRIMARY outcome
Timeframe: Up to 5 weeks after the last courseCount of participants experiencing a dose limiting toxicity. The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 will be used to classify and grade toxicities.
Outcome measures
| Measure |
Treatment (Chemotherapy and Monoclonal Antibody Therapy)
n=48 Participants
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Safety and Toxicity of This Regimen
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 weeks after the last courseResponse will be defined by standard NCI criteria (Cheson et al) for lymphoid malignancies.
Outcome measures
| Measure |
Treatment (Chemotherapy and Monoclonal Antibody Therapy)
n=47 Participants
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Preliminary Assessment of the Efficacy of This Regimen
|
33 Participants
|
SECONDARY outcome
Timeframe: Up to 5 weeks after the last courseOutcome measures
| Measure |
Treatment (Chemotherapy and Monoclonal Antibody Therapy)
n=32 Participants
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Ability to Proceed to Peripheral Blood Stem Cell (PBSC) Collection Following Treatment (Impact of This Regimen on Stem Cell Reserve)
|
30 Participants
|
Adverse Events
Treatment (Chemotherapy and Monoclonal Antibody Therapy)
Serious events: 14 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Chemotherapy and Monoclonal Antibody Therapy)
n=48 participants at risk
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
4/48
|
|
Infections and infestations
Catheter related infection
|
2.1%
1/48
|
|
Gastrointestinal disorders
Obstruction gastric
|
4.2%
2/48
|
|
Immune system disorders
Allergic reaction
|
4.2%
2/48
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
2/48
|
|
General disorders
Fever
|
4.2%
2/48
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
2.1%
1/48
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/48
|
|
Vascular disorders
Hypotension
|
2.1%
1/48
|
|
Infections and infestations
Aseptic Meningitis
|
2.1%
1/48
|
|
Vascular disorders
Vascular access complication
|
2.1%
1/48
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
2.1%
1/48
|
Other adverse events
| Measure |
Treatment (Chemotherapy and Monoclonal Antibody Therapy)
n=48 participants at risk
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
6/48
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
24/48
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
62.5%
30/48
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
4/48
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
4/48
|
|
Infections and infestations
Infection
|
6.2%
3/48
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place