A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-27

Study Completion Date

2016-03-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.

NCT00738374

Lymphocytic Leukemia, Chronic

COMPLETED PHASE2

A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)

NCT01056510

Lymphocytic Leukemia, Chronic

COMPLETED PHASE4

Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia

NCT00281918

Leukemia

COMPLETED PHASE3

An Observational Study on Infusion-related Adverse Events at Administration of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia

NCT01072240

Lymphocytic Leukemia, Chronic

COMPLETED

Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Lymphocytic Leukemia

NCT00046683

B Cell Chronic Lymphocytic Leukemia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphocytic Leukemia, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FCR-lite

Rituximab, fludarabine, and cyclophosphamide

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

150 mg/m\^2 IV or orally on Days 1-3 of each 28-day cycle for 6 cycles

Fludarabine

Intervention Type DRUG

20 mg/m\^2 IV or 32 mg/m2 orally Days 1-3 of each 28-day cycle for 6 cycles

Rituximab

Intervention Type DRUG

375 mg/m2 IV on Day 1 of Cycle 1; 500 mg/m2 IV on Day 1 of Cycles 2-6 (28-day cycles)

LR Therapy

Rituximab and chlorambucile

Group Type ACTIVE_COMPARATOR

Chlorambucil

Intervention Type DRUG

10 mg/m\^2 orally on Days 1-7 of each 28-day cycle for 6 cycles

Rituximab

Intervention Type DRUG

375 mg/m2 IV on Day 1 of Cycle 1; 500 mg/m2 IV on Day 1 of Cycles 2-6 (28-day cycles)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chlorambucil

10 mg/m\^2 orally on Days 1-7 of each 28-day cycle for 6 cycles

Intervention Type DRUG

Cyclophosphamide

150 mg/m\^2 IV or orally on Days 1-3 of each 28-day cycle for 6 cycles

Intervention Type DRUG

Fludarabine

20 mg/m\^2 IV or 32 mg/m2 orally Days 1-3 of each 28-day cycle for 6 cycles

Intervention Type DRUG

Rituximab

375 mg/m2 IV on Day 1 of Cycle 1; 500 mg/m2 IV on Day 1 of Cycles 2-6 (28-day cycles)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MabThera

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No