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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01165112
First Posted: July 19, 2010
Last Update Posted: May 25, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ajay Gopal, University of Washington
Results First Submitted: April 17, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Treatment (Chemotherapy and Monoclonal Antibody Therapy)
STARTED   48 
COMPLETED   48 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Baseline Measures
   Treatment (Chemotherapy and Monoclonal Antibody Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 48 
Age 
[Units: Years]
Median (Full Range)
 56 
 (23 to 69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      19  39.6% 
Male      29  60.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      5  10.4% 
Not Hispanic or Latino      39  81.3% 
Unknown or Not Reported      4   8.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximally Tolerated Dose of Bendamustine Hydrochloride That Can be Combined With Rituximab, Carboplatin, and Etoposide Chemotherapy in Patients With Relapsed or Refractory Lymphoid Malignancies   [ Time Frame: Up to 5 weeks after the last course ]

2.  Primary:   Safety and Toxicity of This Regimen   [ Time Frame: Up to 5 weeks after the last course ]

3.  Secondary:   Preliminary Assessment of the Efficacy of This Regimen   [ Time Frame: Up to 5 weeks after the last course ]

4.  Secondary:   Ability to Proceed to Peripheral Blood Stem Cell (PBSC) Collection Following Treatment (Impact of This Regimen on Stem Cell Reserve)   [ Time Frame: Up to 5 weeks after the last course ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ajay Gopal
Organization: Fred Hutchinson Cancer Research Center
phone: 206-288-2037
e-mail: akgopal@fhcrc.org



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: May 25, 2017