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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00718549
First received: July 16, 2008
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This study will assess the effect of maintenance treatment with MabThera,in comp arison with a 2 year observation period (no treatment),in patients with progress ive B-cell chronic lymphocytic leukemia who have had previous first-line inducti on treatment with MabThera (RCC regimen).After 6 months of induction therapy wit h RCC (MabThera + cladribine + cyclophosphamide) patients will be randomized eit her to receive maintenance treatment with MabThera (375mg/m2 iv every 12 weeks, or to receive no treatment (observation only).The anticipated time on study trea tment 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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response and partial response in induction phase [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: July 2009
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718549

Locations
Belarus
Minsk, Belarus, 220116
Poland
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00718549     History of Changes
Other Study ID Numbers: ML21283, 2008-001140-39
Study First Received: July 16, 2008
Last Updated: October 6, 2014
Health Authority: Poland: Ministry of Health

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cladribine
Cyclophosphamide
Rituximab
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014