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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01056510
First received: January 25, 2010
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This randomized, open-label, parallel group study will assess the effect on resp onse rate and the safety of MabThera added to either bendamustine or chlorambuci l in patients with chronic lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A) MabThera (375mg/m2 iv day 1 of cycle 1, 5 00mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as first-line or 70mg/m2 as se cond-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera plus chlorambu cil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study t reatment is 6-12 months, and target sample size is 600-700 individuals.


Condition Intervention Phase
Lymphocytic Leukemia, Chronic
Drug: rituximab [MabThera/Rituxan]
Drug: bendamustine
Drug: chlorambucil
Phase 4

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 Study to Assess the Effect on Response Rate of MabThera (Rituximab) Added to a Standard Chemotherapy, Bendamustine or Chlorambucil, in Patients With Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Complete response rate [ Time Frame: after 6 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate, complete response, partial response, stable disease, progression-free survival, disease-free survival, time to next leukemia treatment, duration of response, overall survival, molecular response, minimal residual disease [ Time Frame: event-driven, tumour assessment after cycles 3, 6 and 12, and 3-monthly thereafter for at least 1 year ] [ Designated as safety issue: No ]
  • Safety: AEs, laboratory parameters [ Time Frame: throughout study, laboratory parameters every 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 358
Study Start Date: March 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv day 1 of cycle 1, followed by 500mg/m2 iv every 4 weeks cycles 2-6
Drug: bendamustine
90mg/m2 (first-line) or 70mg/m2 (second-line) iv, days 1 and 2 every 4 weeks, cycles 1-6
Experimental: B Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv day 1 of cycle 1, followed by 500mg/m2 iv every 4 weeks cycles 2-6
Drug: chlorambucil
10mg/m2 po days 1-7 every 4 weeks, for up to 12 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >/=18 years of age
  • chronic lymphocytic leukemia
  • active CLL with progressive Binet stage B or C
  • ineligible for treatment with fludarabine
  • for second line patients, only pretreatment with rituximab and/or chlorambucil is allowed
  • EOCG performance status >/=2

Exclusion Criteria:

  • patients who have relapsed within <12 months of first dose of prior rituximab or chlorambucil first-line therapy
  • previous or planned stem cell transplantation
  • radioimmunotherapy within 6 months prior to starting study treatment
  • transformation to aggressive B-cell malignancy
  • any other concurrent anti-cancer therapy, or glucocorticoid >/=20mg daily prednisolone or equivalent
  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: NCT01056510

  Show 85 Study Locations
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: NCT01056510     History of Changes
Other Study ID Numbers: MO22468, 2009-012072-28
Study First Received: January 25, 2010
Last Updated: July 7, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Chlorambucil
Bendamustine
Rituximab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 26, 2014