A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status
- Conditions
- Lymphocytic Leukemia, Chronic
- Interventions
- Registration Number
- NCT01283386
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multi-center, randomized study compared the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in participants with previously untreated B-cell chronic lymphocytic leukemia and unfavorable somatic status. Participants were randomized to receive Mabthera (375 mg/m2 intravenously \[IV\] Day 1 of Cycle 1, 500 mg/m2 IV Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 IV or 32 mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 IV or orally Days 1-3) or with chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study treatment was 24 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FCR-lite Fludarabine Rituximab, fludarabine, and cyclophosphamide FCR-lite Cyclophosphamide Rituximab, fludarabine, and cyclophosphamide LR Therapy Chlorambucil Rituximab and chlorambucile FCR-lite Rituximab Rituximab, fludarabine, and cyclophosphamide LR Therapy Rituximab Rituximab and chlorambucile
- Primary Outcome Measures
Name Time Method Event-free Survival Up to approximately 5 years Event-free survival was defined as the time period from the first day of study treatment to occurrence of any of the following events: appearance of disease progression or relapse; prescription of a new treatment for disease relapse; death caused by B-cell chronic lymphocytic leukemia (B-CLL); or complications from B-CLL or therapy. Relapse was defined as disease progression in participants with complete or partial remission lasting at least 6 months after treatment completion. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by \>50%.
Percentage of Participants With Complete Remission Up to approximately 5 years Complete remission was defined as the disappearance of all signs of disease.
Percentage of Participants With Stable Disease Up to approximately 5 years Stable disease was defined as not meeting the criteria for partial remission or disease progression
Duration of Response Up to approximately 5 years Duration of Response was defined as the time period from the last day of study treatment to the day when disease progression occurred in participants who previously had complete or partial remission. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by \>50%.
Progression-free Survival Up to approximately 5 years Progression-free survival was defined as the time period from the first day of study treatment to the day when disease progression occurred. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.
Percentage of Participants With Disease Progression Up to approximately 5 years Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.
Percentage of Participants With Phenotypic Remission Up to approximately 5 years Phenotypic remission was considered achieved if a participant had a negative test for minimal residual disease. A negative test for minimal residual disease was defined as tumor cells ≤0.01% of the total number of peripheral leukocytes.
Percentage of Participants With Partial Remission Up to approximately 5 years Partial remission was defined as a reduction in tumor size by \>50%.
Overall Survival Up to approximately 5 years Overall survival was defined as the time period from the first day of study treatment to participant death.
Percentage of Participants With Adverse Events (AEs) and Serious AEs Up to approximately 5 years An AE was defined as any unfavorable medical occurrence in a participant receiving a study drug, regardless of relationship the study drug. An AE was considered serious if it met any of the following criteria: was fatal or life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was clinically significant and/or required an intervention to prevent any of the listed criteria.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
City Clinical Hospital #15; Hematology department
🇷🇺Saint-Petersburg, Russian Federation
Republican clinical hospital named after G.G. Kuvatov
🇷🇺UFA, Russian Federation
The order of Honour pin Irkutsk regional clinical hospital; Hematology Department
🇷🇺Irkutsk, Russian Federation
N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
🇷🇺Moscow, Russian Federation
Kemerovo Regional Clinical Hospital
🇷🇺Kemerovo, Russian Federation
GUZ Tula Regioanal Clinical Hospital; Hematology
🇷🇺Tula, Russian Federation
Saint-Petersburg SHI City Clinical Hospital #31
🇷🇺St. Petersburg, Russian Federation
City Clinical Botkin's Hospital; City Hematological Center
🇷🇺Moscow, Russian Federation