This multi-center, single-arm study evaluated the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide in participants with B-cell chronic lymphocytic leukemia (CLL) and favorable somatic status.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Participants received cyclophosphamide 250 mg/m\^2 IV or 250 mg/m\^2 orally on Days 1-3 of each cycle.
Participants received fludarabine 25 mg/m\^2 IV or 40 mg/m\^2 orally on Days 1-3 of each cycle.
Participants received 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle.
The order of Honour pin Irkutsk regional clinical hospital; Hematology Department
Irkutsk, Russia
Kemerovo Regional Clinical Hospital
Kemerovo, Russia
Regional Clinical Oncology Despensary #1; Hematology Department
Krasnodar, Russia
Percentage of Participants With Complete Remission
Complete remission was defined as the disappearance of all signs of disease.
Time frame: Up to approximately 5 years
Percentage of Participants With Disease Progression
Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.
Time frame: Up to approximately 5 years
Percentage of Participants With Stable Disease
Stable disease was defined as not meeting the criteria for partial remission or disease progression
Time frame: Up to approximately 5 years
Percentage of Participants With Partial Remission
Partial remission was defined as a reduction in tumor size by \>50%.
Time frame: Up to approximately 5 years
Duration of Response
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%.
Time frame: Up to approximately 5 years
Progression-free Survival
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.
Time frame: Up to approximately 5 years
Event-free Survival
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N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
Moscow, Russia
City Clinical Hospital After Botkin; Hematology
Moscow, Russia
Saint-Petersburg SHI City Clinical Hospital #31
Saint Petersburg, Russia
City Clinical Hospital #15; Hematology department
Saint Petersburg, Russia
Leningrad Regional Clinical Hospital; Hematology #1
Saint Petersburg, Russia
GUZ Tula Regioanal Clinical Hospital; Hematology
Tula, Russia
Republican clinical hospital named after G.G. Kuvatov
Ufa, Russia
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%.
Time frame: Up to approximately 5 years
Overall Survival
Overall survival was defined as the time period from the first day of study treatment to participant death.
Time frame: Up to approximately 5 years
Percentage of Participants With Phenotypic Remission
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.
Time frame: Up to approximately 5 years
Percentage of Participants With Adverse Events (AEs) and Serious AEs
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.
Time frame: Up to approximately 5 years