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A Study of Maintenance Treatment With MabThera (Rituximab) in Patients With Progressive B-cell Chronic Lymphocytic Leukemia

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 16, 2008
Last updated: November 1, 2016
Last verified: November 2016
This study will assess the effect of maintenance treatment with MabThera,in comparison with a 2 year observation period (no treatment),in patients with progressive B-cell chronic lymphocytic leukemia who have had previous first-line induction treatment with MabThera (RCC regimen).After 6 months of induction therapy with RCC (MabThera + cladribine + cyclophosphamide) patients will be randomized either to receive maintenance treatment with MabThera (375mg/m2 iv every 12 weeks, or to receive no treatment (observation only).The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Lymphocytic Leukemia, Chronic
Drug: cladribine
Drug: cyclophosphamide
Drug: rituximab [MabThera/Rituxan]
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study to Assess the Effect of Maintenance Treatment With MabThera vs no Treatment, After Induction With MabThera, Cladribine and Cyclophosphamide on Progression-free Survival in Previously Untreated Patients With Progressive B-CLL. The Trial Conducted With PALG Sites

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival in the maintenance phase [ Time Frame: Event driven ]

Secondary Outcome Measures:
  • Complete response and partial response in induction phase [ Time Frame: Event driven ]

Enrollment: 128
Study Start Date: July 2009
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: cladribine
0.12mg/kg iv on days 2-4 of each cycle (induction phase)
Drug: cyclophosphamide
250mg/m2 iv on days 2-4 (induction phase)
Drug: rituximab [MabThera/Rituxan]
375mg/m2 on day 1 of cycle 1 (induction phase)
Drug: rituximab [MabThera/Rituxan]
500mg/m2 iv on day 1 of cycles 2-6 (induction phase)
Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv every 12 weeks (maintenance phase)
Active Comparator: 2 Drug: cladribine
0.12mg/kg iv on days 2-4 of each cycle (induction phase)
Drug: cyclophosphamide
250mg/m2 iv on days 2-4 (induction phase)
Drug: rituximab [MabThera/Rituxan]
375mg/m2 on day 1 of cycle 1 (induction phase)
Drug: rituximab [MabThera/Rituxan]
500mg/m2 iv on day 1 of cycles 2-6 (induction phase)


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • confirmed diagnosis of B-cell chronic lymphocytic leukemia;
  • stage I-IV disease with evidence of progression;
  • no previous chemotherapy, radiotherapy or immunotherapy for B-cell chronic lymphocytic leukemia;
  • ECOG PS 0-2.

Exclusion Criteria:

  • active secondary malignancy or transformation to aggressive lymphoma;
  • medical condition requiring chronic use of oral corticosteroids at a dose of 1mg/kg or 60 mg/m2 over 2 weeks;
  • prior treatment with interferon, MabThera or another monoclonal antibody, immunosuppressive treatment or radiotherapy for 12 months before study start;
  • history of other malignancies within 2 years before study entry, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00718549

Minsk, Belarus, 220116
Bialystok, Poland, 15-276
Krakow, Poland, 31-501
Lodz, Poland, 93-510
Warszawa, Poland, 02 776
Wroclaw, Poland, 50-367
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00718549     History of Changes
Other Study ID Numbers: ML21283
Study First Received: July 16, 2008
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists processed this record on May 25, 2017