Status:
COMPLETED
Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial
Lead Sponsor:
Institut Bergonié
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Lymphoma
Eligibility:
All Genders
70-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them o...
Detailed Description
OBJECTIVES: Primary * To assess the therapeutic efficacy of rituximab, cyclophosphamide, vincristine sulfate, and prednisone with vs without liposome-encapsulated doxorubicin citrate, in terms of co...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of diffuse large B-cell non-Hodgkin lymphoma
- Stage II, III, or IV disease (according to the WHO classification), including all morphological and clinical variants
- No Burkitt-like lymphoma (presence of small cells in the bone marrow biopsy allowed)
- CD20+ disease
- Has ≥ 1 measurable target lesion ≥ 1.1 cm (according to the International Workshop Criteria)
- Poor physiological status, as defined by ≥ 1 of the following criteria:
- WHO performance status 3
- Clinical evaluation and measurement of LVEF that would preclude doxorubicin administration (i.e., LVEF \< 50%)
- Creatinine clearance \< 50 mL/min
- Serum bilirubin \> 30 μmol/L
- Severe comorbidity that would preclude the use of CHOP chemotherapy
- Ineligible for standard R-CHOP therapy
- No cerebral or meningeal involvement
- PATIENT CHARACTERISTICS:
- WHO performance status 0-3
- ANC \> 750/mm\^3
- Platelet count \> 50,000/mm\^3
- LVEF \> 35%
- Able to receive either R-COP or R-COPY therapy
- No congestive heart failure, serious arrhythmia, or myocardial infarction within the past 6 months
- No other malignancy within the past 5 years except for adequately treated basal cell carcinoma of the skin or curatively treated carcinoma in situ of the cervix
- No active infection
- No active viral hepatitis B or C by serology
- No known HIV positivity
- No hypersensitivity to rituximab, any of its excipients, or to murine proteins
- No documented history of allergy to eggs or egg products
- No psychological, familial, sociological, or geographical condition that would preclude compliance with study treatment or follow-up schedule
- PRIOR CONCURRENT THERAPY:
- No prior therapy for this cancer
- No prior anthracycline administration with a cumulative dose \> 240 mg/m² of doxorubicin hydrochloride or \> 400 mg/m² of epirubicin hydrochloride
- More than 30 days since prior participation in another clinical trial involving investigational drugs
- No other concurrent antineoplastic agents
Exclusion
Key Trial Info
Start Date :
December 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00911183
Start Date
December 2 2008
End Date
January 1 2015
Last Update
August 29 2025
Active Locations (1)
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1
Institut Bergonie
Bordeaux, France, 33076