Prospective Study of Efficacy and Safety of RFC (Rituximab, Fludarabine, Cyclophosphamide) Regimen as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Favorable Somatic Status
Phase 4
18 Years
70 Years
18 Years
70 Years
Open (Enrolling)
Both
Lymphocytic Leukemia, Chronic
Both
Lymphocytic Leukemia, Chronic
Trial Information
Prospective Study of Efficacy and Safety of RFC (Rituximab, Fludarabine, Cyclophosphamide) Regimen as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Favorable Somatic Status
Inclusion Criteria:
- Adult patients, age 18-70 years
- Diagnosis of previously untreated B-cell chronic lymphocytic leukemia
- For patients, age 60-70 years: Cumulative Illness Rating Scale (CIRS) comorbidity
score
- Binet stage B, C or A with progression
- Life expectancy >/=12 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria:
- Patients with small-cell lymphoma
- Patients with auto-immune hemolytic anemia
- Concomitant malignant disease during enrollment, except basal cell carcinoma of the
skin
- Chemotherapy for concomitant disease give within 12 months prior to study enrollment
- Patients with 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 of MabThera in combination with fludarabine and cyclophosphamide
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:
ML25136
NCT ID:
NCT01271010
Start Date:
June 2011
Completion Date:
October 2018
Related Keywords:
- Lymphocytic Leukemia, Chronic
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Chronic Disease
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