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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
817
Intravenous repeating dose
Intravenous repeating dose
Intravenous repeating dose
Progression-free Survival (PFS)
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.
Time frame: Median observation time at time of analysis was approximately 21 months
Final Analysis: Time to Progression-free Survival Event
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.
Time frame: Median observation time was approximately 66.4 months
Event-free Survival (EFS)
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.
Time frame: Median observation time at time of analysis was approximately 21 months
Overall Survival (OS)
Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.
Time frame: Median observation time at time of analysis was approximately 21 months
Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).
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.
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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
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
Vienna, Austria
Hanuschkrankenhaus
Vienna, Austria
Rudolfinerhaus
Vienna, Austria
AZ Sint-Jan
Bruges, Belgium
...and 152 more locations
Time frame: Median observation time at time of analysis was approximately 21 months
Final Analysis: Time to Overall Survival Event
Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.
Time frame: Median observation time was approximately 66.4 months
Final Analysis: Time to Event-free Survival Event
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.
Time frame: Median observation time was approximately 66.4 months
Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)
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
Time frame: Median observation time was approximately 66.4 months
Final Analysis: Duration of Response
Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.
Time frame: Median observation time was approximately 66.4 months
Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response
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.
Time frame: Median observation time was approximately 66.4 months
Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)
The time from randomization to the start of a new treatment.
Time frame: Median observation time was approximately 66.4 months