Clinical trial NCT01271010: A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status
Official title: Prospective Study of Efficacy and Safety of RFC (Rituximab, Fludarabine, Cyclophosphamide) Regimen as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Favorable Somatic Status
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Lymphocytic Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-01-06
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of previously untreated B-cell CLL confirmed immunophenotypically
* For participants, age 60-70 years: Cumulative Illness Rating Scale (CIRS) comorbidity score less than or equal to (\</=) 6
* Binet stage B, C or A with progression
* Life expectancy greater than or equal to (\>/=) 12 months
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Women of child bearing potential and men should agree to use highly reliable contraceptive method throughout the treatment period and within 12 months after treatment completion

Exclusion Criteria:

* Participants with small-cell lymphoma
* Participants with auto-immune hemolytic anemia
* Concomitant malignant disease during enrollment, except basal cell carcinoma of the skin
* Chemotherapy for concomitant malignant disease given within 12 months prior to study enrollment
* Participants with Richter's Syndrome
* Participants with symptomatic Hepatitis B infection
* Any clinically significant infection that could not be cured prior to enrollment, including Human Immunodeficiency Virus (HIV) infection
* Creatinine clearance less than (\<) 30 milliliters per minute (mL/min)
* Participants with congestive heart failure (CHF) New York Heart Association (NYHA) III-IV
* Participants with liver failure and acute hepatitis of any etiology
* Any other medical or mental condition which may preclude from receiving the entire course of protocol specified treatment or signing the informed consent
* History of an anaphylactic reaction to murine antibodies, proteins, or any other ingredient of rituximab
* Pregnancy and breast-feeding women

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: Krasnodar
country: Russian Federation
facility: Regional Clinical Oncology Despensary #1; Hematology Department
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 Hospital After Botkin; Hematology
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Hospital #15; Hematology department
city: St Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital; Hematology #1
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: