Status:
COMPLETED
Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
Cephalon
Conditions:
Diffuse Large B-Cell Lymphoma
Lymphoma, Diffuse Large-Cell
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to learn about the safety of the treatment with a combination of bendamustine and rituximab and to find out what effects, both good and bad this treatment has on ...
Detailed Description
This multicenter Phase II clinical study will investigate the complete response (CR) rate after therapy with bendamustine combined with rituximab in older (≥65 years old) patients with previously untr...
Eligibility Criteria
Inclusion
- Patients with previously untreated , histologically confirmed, diffuse large B-cell lymphoma (DLBCL), immunophenotyped for CD20
- Age greater than or equal to 65 years
- Stage II-IV
- Measurable disease including lesions that can be accurately measured in 2 dimensions by CT and have a greatest transverse diameter of 1cm or greater, and/or by bone marrow histopathology.
- ECOG performance status of 0-3
- Deemed poor candidate for CHOP-R due to ejection fraction less than or equal to 45%, ECOG performance status of 2, or in the opinion of the treating physician, patient would not tolerate administration of CHOP-R chemotherapy for other reasons,
- Life expectancy of at least 3 months;
- Documented negative serologic testing for HIV, Hepatitis B (unless positive due to prior vaccination), and hepatitis C within the year prior to enrollment
- Adequate bone marrow function (without transfusion support within one week of screening) function:
- Hemoglobin \> 8 g/dL
- Absolute neutrophil count (ANC) \>1000 cells/mm3
- Platelet count \> 75,000/mm3
- Adequate hepatic and renal function as demonstrated by:
- Aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (ULN)
- Total serum bilirubin \< 2.5 x ULN
- Serum creatinine \< 1.5 x ULN
- If sexually active male of reproductive capability, has agreed to use a medically accepted form of contraception from time of enrollment to completion of all follow-up study visits
- Signed an institutional review board (IRB) approved informed consent document
Exclusion
- Central nervous system involvement by lymphoma
- History of previous allergic reactions to compounds of similar biological or chemical composition as rituximab or bendamustine
- Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective.
- Other active malignancies (except: non-melanoma skin cancer, cervical carcinoma in situ without evidence of disease, prostatic intraepithelial neoplasia without evidence of prostate cancer)
- Patients on strong inhibitors of CYP1A2.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01234467
Start Date
March 1 2011
End Date
August 1 2016
Last Update
May 24 2017
Active Locations (7)
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1
Seby B. Jones Cancer Center
Boone, North Carolina, United States, 28607
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
3
Northeast Medical Center
Concord, North Carolina, United States, 28025
4
Moses Cone Regional Cancer Center
Greensboro, North Carolina, United States, 27403