A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-17

Study Completion Date

2016-05-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphocytic Leukemia, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rituximab + Fludarabine + Cyclophosphamide

Participants received rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m\^2 IV or 40 mg/m\^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m\^2 IV or 250 mg/m\^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Participants received cyclophosphamide 250 mg/m\^2 IV or 250 mg/m\^2 orally on Days 1-3 of each cycle.

Fludarabine

Intervention Type DRUG

Participants received fludarabine 25 mg/m\^2 IV or 40 mg/m\^2 orally on Days 1-3 of each cycle.

Rituximab

Intervention Type DRUG

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.

Interventions

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Cyclophosphamide

Participants received cyclophosphamide 250 mg/m\^2 IV or 250 mg/m\^2 orally on Days 1-3 of each cycle.

Intervention Type DRUG

Fludarabine

Participants received fludarabine 25 mg/m\^2 IV or 40 mg/m\^2 orally on Days 1-3 of each cycle.

Intervention Type DRUG

Rituximab

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.

Intervention Type DRUG

Other Intervention Names

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MabThera

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No