Completed

A Randomized, Open Label Study to Assess the Effect of Maintenance Treatment With Mabthera (Rituximab) Versus No Treatment, After Induction Treatment With Rituximab, Cladribine and Cyclophosphamide (RCC) on Progression-Free Survival in Previously Untreated Patients With Progressive B-Cell Chronic Lymphocytic Leukemia

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What is being tested

Cladribine

+ Cyclophosphamide

+ Rituximab

Drug
Who is being recruted

Chronic Disease+13

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2009
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 21, 2009

Actual date on which the first participant was enrolled.

This study will assess the effect of maintenance treatment with rituximab in comparison with observation period (no treatment), in participants with progressive B-cell CLL who have had previous first-line induction treatment with rituximab, cladribine and cyclophosphamide (RCC regimen). After 6 months of RCC induction therapy, participants will be randomized either to receive maintenance treatment with rituximab or to receive no treatment (observation only) for 96 weeks. Participants completing maintenance/observation period will be followed-up for approximately 3 years.

Official TitleA Randomized, Open Label Study to Assess the Effect of Maintenance Treatment With Mabthera (Rituximab) Versus No Treatment, After Induction Treatment With Rituximab, Cladribine and Cyclophosphamide (RCC) on Progression-Free Survival in Previously Untreated Patients With Progressive B-Cell Chronic Lymphocytic Leukemia
NCT00718549
Principal SponsorHoffmann-La Roche
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

128 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLeukemia, Lymphocytic, Chronic, B-CellDisease Attributes

Criteria

Inclusion Criteria: * Immunologically confirmed diagnosis of B-cell CLL * Rai stage I-IV disease with evidence of progression * No previous chemotherapy, radiotherapy, or immunotherapy for B-cell CLL * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: * Active secondary malignancy or transformation to aggressive lymphoma * Medical condition requiring chronic use of oral corticosteroids at a dose of 1 mg/kg or 60 mg/m\^2 over 2 weeks * Prior treatment with interferon, rituximab or another monoclonal antibody, immunosuppressive treatment or radiotherapy before inclusion to the study * History of other malignancies within 2 years before study entry, except for dequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive rituximab at a dose of 375 milligrams per meter squared (mg/m\^2) as intravenous (IV) infusion on Day 1, cladribine at a dose of 0.12 milligrams per kilogram per day (mg/kg/day) as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m\^2/day as IV infusion over 15-30 minutes on Days 2-4 in Cycle 1. Then, rituximab at a dose of 500 mg/m\^2 as IV infusion on Day 1, cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m\^2/day as IV infusion over 15-30 minutes on Days 2-4 will be administered in Cycles 2-6. Each cycle will be of 28 days in duration.

Group II

Experimental
Participants with PR or CR after induction phase who will be randomized to maintenance arm will receive rituximab treatment for 8 cycles. Twelve weeks after the last induction cycle, participants will receive rituximab at a dose of 375 mg/m\^2 as IV infusion on Day 1 of each 12-week cycle until disease progression (up to approximately 96 weeks).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

City Clinical Hospital #9

Minsk, BelarusOpen City Clinical Hospital #9 in Google Maps
Suspended

Medical University, Independent Public Clinical Hospital; Dept. of Hematology, SPSK

Bialystok, Poland
Suspended

Szpital Uniwersytecki W Krakowie; Klinika Hematologii

Krakow, Poland
Suspended

Medical University School; Dept. of Haematology

Lodz, Poland
Completed6 Study Centers