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Trial record 20 of 23 for:    CD20 Fred Hutchinson

Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma (TREC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01165112
Recruitment Status : Completed
First Posted : July 19, 2010
Results First Posted : May 25, 2017
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ajay Gopal, University of Washington

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Interventions Drug: Bendamustine Hydrochloride
Drug: Carboplatin
Biological: Rituximab
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Chemotherapy and Monoclonal Antibody Therapy)
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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

Period Title: Overall Study
Started 48
Completed 48
Not Completed 0
Arm/Group Title Treatment (Chemotherapy and Monoclonal Antibody Therapy)
Hide Arm/Group Description

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 Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 48 participants
56
(23 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
19
  39.6%
Male
29
  60.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Hispanic or Latino
5
  10.4%
Not Hispanic or Latino
39
  81.3%
Unknown or Not Reported
4
   8.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   4.2%
Native Hawaiian or Other Pacific Islander
1
   2.1%
Black or African American
1
   2.1%
White
43
  89.6%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.1%
1.Primary Outcome
Title Maximally Tolerated Dose of Bendamustine Hydrochloride That Can be Combined With Rituximab, Carboplatin, and Etoposide Chemotherapy in Patients With Relapsed or Refractory Lymphoid Malignancies
Hide Description 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.
Time Frame Up to 5 weeks after the last course
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy and Monoclonal Antibody Therapy)
Hide Arm/Group Description:

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 Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: mg/m2 x 2
120
2.Primary Outcome
Title Safety and Toxicity of This Regimen
Hide Description Count 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.
Time Frame Up to 5 weeks after the last course
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy and Monoclonal Antibody Therapy)
Hide Arm/Group Description:

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 Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Preliminary Assessment of the Efficacy of This Regimen
Hide Description Response will be defined by standard NCI criteria (Cheson et al) for lymphoid malignancies.
Time Frame Up to 5 weeks after the last course
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy and Monoclonal Antibody Therapy)
Hide Arm/Group Description:

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 Number of Participants Analyzed 47
Measure Type: Count of Participants
Unit of Measure: Participants
33
  70.2%
4.Secondary Outcome
Title Ability to Proceed to Peripheral Blood Stem Cell (PBSC) Collection Following Treatment (Impact of This Regimen on Stem Cell Reserve)
Hide Description [Not Specified]
Time Frame Up to 5 weeks after the last course
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy and Monoclonal Antibody Therapy)
Hide Arm/Group Description:

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 Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
30
  93.8%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Chemotherapy and Monoclonal Antibody Therapy)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Chemotherapy and Monoclonal Antibody Therapy)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Chemotherapy and Monoclonal Antibody Therapy)
Affected / at Risk (%)
Total   14/48 (29.17%) 
Blood and lymphatic system disorders   
Febrile neutropenia  4/48 (8.33%) 
Cardiac disorders   
Atrial fibrillation  1/48 (2.08%) 
Gastrointestinal disorders   
Obstruction gastric  2/48 (4.17%) 
General disorders   
Fever  2/48 (4.17%) 
Immune system disorders   
Allergic reaction  2/48 (4.17%) 
Infections and infestations   
Catheter related infection  1/48 (2.08%) 
Aseptic Meningitis  1/48 (2.08%) 
Metabolism and nutrition disorders   
Dehydration  2/48 (4.17%) 
Respiratory, thoracic and mediastinal disorders   
Asthma exacerbation  1/48 (2.08%) 
Upper respiratory infection  1/48 (2.08%) 
Vascular disorders   
Hypotension  1/48 (2.08%) 
Vascular access complication  1/48 (2.08%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Chemotherapy and Monoclonal Antibody Therapy)
Affected / at Risk (%)
Total   46/48 (95.83%) 
Blood and lymphatic system disorders   
Anemia  6/48 (12.50%) 
Neutropenia  24/48 (50.00%) 
Thrombocytopenia  30/48 (62.50%) 
Febrile neutropenia  4/48 (8.33%) 
Infections and infestations   
Infection  3/48 (6.25%) 
Metabolism and nutrition disorders   
Dehydration  4/48 (8.33%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ajay Gopal
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-288-2037
EMail: akgopal@fhcrc.org
Layout table for additonal information
Responsible Party: Ajay Gopal, University of Washington
ClinicalTrials.gov Identifier: NCT01165112     History of Changes
Other Study ID Numbers: PSOC 2502
NCI-2010-00907 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PSOC 2502 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: June 21, 2010
First Posted: July 19, 2010
Results First Submitted: April 17, 2017
Results First Posted: May 25, 2017
Last Update Posted: December 5, 2018