Prospective Randomized Study to Compare Efficacy and Safety of RFC-lite (Rituximab, Fludarabine, Cyclophosphamide) Regimen With LR (Rituximab, Chlorambucil) as a First-line Therapy in Patients With B-cell Chronic Lymphocytic Leukemia and Unfavorable Somatic Status
Phase 4
60 Years
N/A
60 Years
N/A
Open (Enrolling)
Both
Lymphocytic Leukemia, Chronic
Both
Lymphocytic Leukemia, Chronic
Trial Information
Prospective Randomized Study to Compare Efficacy and Safety of RFC-lite (Rituximab, Fludarabine, Cyclophosphamide) Regimen With LR (Rituximab, Chlorambucil) as a First-line Therapy in Patients With B-cell Chronic Lymphocytic Leukemia and Unfavorable Somatic Status
Inclusion Criteria:
- Adult patients, 60-70 or >70 years of age
- Cumulative Illness Rating Scale (CIRS) comorbidity score >/=7 if patient is 60-70
years old
- Previously untreated B-cell chronic lymphocytic leukemia
- Binet stage B, C or A with progression
- ECOG performance status 0-2
Exclusion Criteria:
- Small-cell lymphoma
- Autoimmune hemolytic anemia
- Concomitant malignant disease during enrollment, except for basal cell carcinoma of
the skin
- Chemotherapy for concomitant malignant disease within 12 months prior to study
enrollment
- Richter's syndrome
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Therapy response rate
Outcome Time Frame:
60 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Russia: Ministry of Health of the Russian Federation
Study ID:
ML25137
NCT ID:
NCT01283386
Start Date:
April 2011
Completion Date:
July 2017
Related Keywords:
- Lymphocytic Leukemia, Chronic
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Chronic Disease
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