Status:
COMPLETED
A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Lymphocytic Leukemia, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 21 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2015
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00718549
Start Date
July 21 2009
End Date
September 14 2015
Last Update
August 20 2018
Active Locations (6)
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1
City Clinical Hospital #9
Minsk, Belarus, 220116
2
Medical University, Independent Public Clinical Hospital; Dept. of Hematology, SPSK
Bialystok, Poland, 15-276
3
Szpital Uniwersytecki W Krakowie; Klinika Hematologii
Krakow, Poland, 31-501
4
Medical University School; Dept. of Haematology
Lodz, Poland, 93-510