Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 817
- Locations
- 160
- Primary Endpoint
- Progression-free Survival (PFS)
Overview
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 lymphocytic leukemia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Fludarabine+Cyclophosphamide+Rituximab (FCR)
Intervention: Rituximab (Drug)
Fludarabine+Cyclophosphamide+Rituximab (FCR)
Intervention: Cyclophosphamide (Drug)
Fludarabine+Cyclophosphamide+Rituximab (FCR)
Intervention: Fludarabine Phosphate (Drug)
Fludarabine+Cyclophosphamide (FC)
Intervention: Cyclophosphamide (Drug)
Fludarabine+Cyclophosphamide (FC)
Intervention: Fludarabine Phosphate (Drug)
Outcomes
Primary Outcomes
Progression-free Survival (PFS)
Time Frame: Median observation time at time of analysis was approximately 21 months
Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.
Final Analysis: Time to Progression-free Survival Event
Time Frame: Median observation time was approximately 66.4 months
Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.
Secondary Outcomes
- Event-free Survival (EFS)(Median observation time at time of analysis was approximately 21 months)
- Overall Survival (OS)(Median observation time at time of analysis was approximately 21 months)
- Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).(Median observation time at time of analysis was approximately 21 months)
- Final Analysis: Time to Overall Survival Event(Median observation time was approximately 66.4 months)
- Final Analysis: Time to Event-free Survival Event(Median observation time was approximately 66.4 months)
- Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)(Median observation time was approximately 66.4 months)
- Final Analysis: Duration of Response(Median observation time was approximately 66.4 months)
- Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response(Median observation time was approximately 66.4 months)
- Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)(Median observation time was approximately 66.4 months)