Status:
COMPLETED
Rituximab Maintenance Versus Observation After First-line Immunochemotherapy by FCR in Older Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
University Hospital, Tours
Collaborating Sponsors:
Roche Pharma AG
French Innovative Leukemia Organisation
Conditions:
Leukemia
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Classical chemotherapy does not cure advanced chronic lymphocytic leukemia (CLL) despite new drugs. Rituximab is a monoclonal antibody directed against CD20 surface antigen on B lymphocytes...
Detailed Description
OBJECTIVES: Primary * To demonstrate superiority, in terms of 3-year progression-free survival (PFS), of rituximab maintenance over observation in patients who are in complete or partial response (C...
Eligibility Criteria
Inclusion
- Inclusion criteria
- B-CLL
- Matutes score 4 or 5
- Binet stages B or C
- Age \> 65 years old
- No previous treatment of CLL by chemotherapy, radiotherapy or immunotherapy, except glucocorticoids \< 1 month
- Patient's written informed consent
- Life expectancy \> 6 months
- Exclusion criteria
- Binet stage A
- ECOG performance status 2 or more
- Presence of a 17p deletion by FISH (\> 10% positive cores)
- Clinically significant auto-immune cytopenia, Coombs-positive hemolytic anemia as judged by the treating physician
- Patients with a history of another malignancy in complete remission less than 5 years, except basal cell skin cancer or tumor treated curatively by surgery
- Concomitant disease requiring prolonged use of corticosteroids (\> 1 month)
- Any severe co-morbidities such as NYHA Class III or IV heart failure, myocardial infarction within 6 months, unstable angina, ventricular tachyarrhythmias requiring ongoing treatment, severe uncontrolled myocardiopathy, uncontrolled hypertension, severe chronic obstructive pulmonary disease with hypoxemia, or uncontrolled diabetes mellitus.
- CIRS (Cumulative Illness rating Scale) \> 6
- Known hypersensitivity to murine proteins or to any of the study drugs or to their components
- Transformation into an aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin lymphoma) or prolymphocytic leukemia
- Active bacterial, viral or fungal infection
- Seropositivity HIV, hepatitis C or hepatitis B (unless clearly due to vaccination)
- Total bilirubin, alkaline phosphatases and aminotransferases \> 2 x ULN
- Creatinine clearance \< 60 ml/min calculated according to the formula of Cockcroft and Gault
- Any coexisting medical or psychological condition that would preclude participation to the required study procedures
- Patient with mental deficiency preventing proper understanding of the requirements of treatment
- Inclusion criteria at randomization
- Patients having received the full induction phase with 4 FC and 6 rituximab courses (with/without dose adjustments as per protocol)
- Complete or partial response according to NCI and iwCLL criteria at the end of induction phase
- Recovery from FCR toxicities
- Patient willingness to continue on protocol
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
542 Patients enrolled
Trial Details
Trial ID
NCT00645606
Start Date
December 1 2007
End Date
July 1 2017
Last Update
August 1 2017
Active Locations (1)
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1
French Innovative leukemia Organization
Tours, France, 37044