Status:
COMPLETED
FCR or BR in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia
Lead Sponsor:
German CLL Study Group
Collaborating Sponsors:
Roche Pharma AG
Mundipharma Pte Ltd.
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping th...
Detailed Description
OBJECTIVES: * To compare the therapeutic efficacy of fludarabine phosphate, cyclophosphamide, and rituximab vs bendamustine hydrochloride and rituximab in patients with previously untreated B-cell ch...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting 1 of the following criteria:
- Binet stage C disease or stage B or A disease requiring treatment
- Binet stage B or A disease meeting ≥ 1 of the following:
- B-symptoms (e.g., night sweats, weight loss ≥ 10% within the past 6 months, fevers \> 38°C or 100.4°F for ≥ 2 weeks without evidence of infection) or constitutional symptoms (e.g., fatigue)
- Progressive lymphocytosis, defined as peripheral lymphocyte count \> 5 x 10\^9/L (i.e., \> 50% increase over a 2-month period or doubling of peripheral blood lymphocyte count \< 6 months)
- Evidence of progressive marrow failure as manifested by the development/worsening of anemia and/or thrombocytopenia
- Massive, progressive, or painful splenomegaly or hypersplenism
- Massive lymph nodes or lymph node clusters (\> 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
- No 17p deletion by FISH
- No aggressive B-cell cancer, such as Richter syndrome
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 6 months
- Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless directly attributable to CLL)
- AST and ALT ≤ 2 times ULN (unless directly attributable to CLL)
- Creatinine clearance ≥ 70 mL/min (creatinine clearance is to be calculated only in patients with serum creatinine ≥ 1.1 mg/dL)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
- Hepatitis B and C negative
- HIV negative
- CIRS score \> 6 or a single score of 4 for one organ category
- No active secondary malignancy requiring treatment, except basal cell carcinoma or malignant tumor curatively treated by surgery, or successfully treated secondary malignancies in complete remission \> 5 years prior to enrollment
- No history of anaphylaxis following exposure to monoclonal antibodies
- No active bacterial, viral, or fungal infection
- No medical condition requiring prolonged use of oral corticosteroids (i.e., \> 1 month)
- No cerebral dysfunction or legal incapacity
- No circumstance that would preclude completion of the study or the required follow-up
- PRIOR CONCURRENT THERAPY:
- No prior CLL specific-chemotherapy, radiotherapy, and/or immunotherapy
- Prednisolone administered immediately prior to initiation of study therapy allowed for very high lymphocyte counts
- No concurrent participation in another clinical trial
Exclusion
Key Trial Info
Start Date :
October 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
564 Patients enrolled
Trial Details
Trial ID
NCT00769522
Start Date
October 2 2008
End Date
January 1 2018
Last Update
December 31 2024
Active Locations (1)
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1
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, Germany, D-50924