Clinical trial NCT01283386: A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status
Official title: Prospective Randomized Study to Compare Efficacy and Safety of RFC-Lite (Rituximab, Fludarabine, Cyclophosphamide) Regimen With LR (Rituximab, Chlorambucil) as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Unfavorable Somatic Status
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Lymphocytic Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 26
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Complete Remission
timeFrame: Up to approximately 5 years
measure: Percentage of Participants With Disease Progression
timeFrame: Up to approximately 5 years
measure: Percentage of Participants With Stable Disease
timeFrame: Up to approximately 5 years
measure: Percentage of Participants With Partial Remission
timeFrame: Up to approximately 5 years
measure: Duration of Response
timeFrame: Up to approximately 5 years
measure: Progression-free Survival
timeFrame: Up to approximately 5 years
measure: Event-free Survival
timeFrame: Up to approximately 5 years
measure: Overall Survival
timeFrame: Up to approximately 5 years
measure: Percentage of Participants With Phenotypic Remission
timeFrame: Up to approximately 5 years
measure: Percentage of Participants With Adverse Events (AEs) and Serious AEs
timeFrame: Up to approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Irkutsk
country: Russian Federation
facility: The order of Honour pin Irkutsk regional clinical hospital; Hematology Department
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
city: Moscow
country: Russian Federation
facility: City Clinical Botkin's Hospital; City Hematological Center
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Hospital #15; Hematology department
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg SHI City Clinical Hospital #31
city: Tula
country: Russian Federation
facility: GUZ Tula Regioanal Clinical Hospital; Hematology
city: UFA
country: Russian Federation
facility: Republican clinical hospital named after G.G. Kuvatov
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: