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
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Lymphocytic Leukemia, Chronic
Both
Lymphocytic Leukemia, Chronic
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete response rate
Outcome Time Frame:
after 6 cycles
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
MO22468
NCT ID:
NCT01056510
Start Date:
March 2010
Completion Date:
July 2014
Related Keywords:
- Lymphocytic Leukemia, Chronic
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Chronic Disease
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