Status:
COMPLETED
Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
German CLL Study Group
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosed B-cell chronic lymphocytic leukemia (CLL) defined by the National Cancer Institute (NCI) Working Group criteria
- Meets 1 of the following criteria:
- Binet stage C disease
- Binet stage B disease AND ≥ 1 of the following signs or symptoms\*:
- B symptoms (night sweats, weight loss ≥ 10% within the previous 6 months, fevers \> 38°C or 100.4°F for ≥ 2 weeks without evidence of infection), or constitutional symptoms (fatigue)
- Continuous progression (doubling of peripheral lymphocyte count within the past 6 months and absolute lymphocyte count \> 50 G/I)
- 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), danger of organ complications through large lymphoma (e.g., vascular compression or tracheal narrowing), or progressive lymphadenopathy
- Occurrence of symptomatic hyperviscosity problems at leukocyte counts \> 200 G/I (symptomatic leukostasis) NOTE: \* Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility
- No Binet stage A disease
- No transformation to an aggressive B-cell malignancy (e.g., diffuse large cell lymphoma, Richter's syndrome, or prolymphocytic leukemia)
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Cumulative Illness Rating Scale (CIRS) score \> 6
- Life expectancy \> 6 months
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- Alkaline phosphatase and transaminases ≤ 2 times ULN
- Creatinine clearance ≥ 70 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study treatment
- No known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs
- No cerebral dysfunction that precludes chemotherapy
- No active bacterial, viral, or fungal infection
- No clinically significant autoimmune cytopenia or Coombs-positive hemolytic anemia
- No other active malignancy requiring concurrent treatment except basal cell carcinoma or tumors treated curatively by surgery
- No medical or psychological condition that would preclude study therapy
- No concurrent disease that requires prolonged (\> 1 month) therapy involving glucocorticoids
- PRIOR CONCURRENT THERAPY:
- No previous treatment of CLL by chemotherapy, radiotherapy, or immunotherapy
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
817 Patients enrolled
Trial Details
Trial ID
NCT00281918
Start Date
July 1 2003
End Date
October 1 2011
Last Update
September 19 2013
Active Locations (162)
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1
Gosford Hospital
Gosford, New South Wales, Australia, 2250
2
Westmead Institute for Cancer Research at Westmead Hospital
Westmead - Wentworthville, New South Wales, Australia, 2145
3
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
4
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102