Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia
- Conditions
- Leukemia
- Interventions
- Registration Number
- NCT00281918
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 817
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fludarabine+Cyclophosphamide+Rituximab (FCR) Rituximab - Fludarabine+Cyclophosphamide+Rituximab (FCR) Cyclophosphamide - Fludarabine+Cyclophosphamide+Rituximab (FCR) Fludarabine Phosphate - Fludarabine+Cyclophosphamide (FC) Cyclophosphamide - Fludarabine+Cyclophosphamide (FC) Fludarabine Phosphate -
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) 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 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 Outcome Measures
Name Time Method Event-free Survival (EFS) Median observation time at time of analysis was approximately 21 months Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.
Overall Survival (OS) Median observation time at time of analysis was approximately 21 months Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.
Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR). Median observation time at time of analysis was approximately 21 months CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.
Final Analysis: Time to Overall Survival Event Median observation time was approximately 66.4 months Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.
Final Analysis: Time to Event-free Survival Event Median observation time was approximately 66.4 months Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause.
Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR) Median observation time was approximately 66.4 months CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death
Final Analysis: Duration of Response Median observation time was approximately 66.4 months Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.
Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response Median observation time was approximately 66.4 months CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.
Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL) Median observation time was approximately 66.4 months The time from randomization to the start of a new treatment.
Trial Locations
- Locations (160)
Gosford Hospital
🇦🇺Gosford, New South Wales, Australia
Westmead Institute for Cancer Research at Westmead Hospital
🇦🇺Westmead - Wentworthville, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
Hanuschkrankenhaus
🇦🇹Vienna, Austria
Rudolfinerhaus
🇦🇹Vienna, Austria
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
🇦🇹Wien, Austria
AZ Sint-Jan
🇧🇪Brugge, Belgium
Scroll for more (150 remaining)Gosford Hospital🇦🇺Gosford, New South Wales, Australia