A Phase 3 interventional study of Rituximab in Leukemia, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2017-08-01.
Sponsored by University Hospital, Tours · Phase 3, Interventional, and Treatment
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 and leads to apoptosis of CD20 positive B lymphocytes. The highest response rate yet published in the treatment of first-line CLL has been obtained by the association of fludarabine, cyclophosphamide and rituximab (FCR). Now, the question is whether this response can be improved, as some trials showed that eradication of minimal residual disease (MRD) in CLL is associated with a longer treatment-free and overall survival. Maintenance therapy using rituximab has been recently approved as a means of prolonging remission in patients with indolent non Hodgkin's lymphoma. Maintenance therapy with rituximab could be of interest in treatment of MRD in CLL and prolonging remission and survival times.
PURPOSE: The overall purpose of the study is to determine the value of immunotherapy maintenance with single agent rituximab in comparison with no further treatment (observation ) for previously untreated chronic lymphocytic leukaemia in elderly (>65 years) patients who respond to induction immunochemotherapy with FCR.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Randomization is stratified according to response to induction therapy (complete response [CR] vs partial response [PR]), IGHV mutational status, and 11q deletion.
Patients receive rituximab IV on days 1 and 14 of courses 1-2 and on day 1 of courses 3 and 4. Patients also receive oral fludarabine and oral cyclophosphamide once daily on days 2-4 of course 1 and on days 1-3 of courses 2-4. Courses are administered every 28 days. Patients achieving CR or PR are randomized 1:1 to maintenance arm or observation arm.
After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for 2 years.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 542 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria
Exclusion criteria
Inclusion criteria at randomization
Observation every 8 weeks during 2 years
rituximab :500 mg/m² every 8 weeks during 2 years
Biological: Rituximab
rituximab :500 mg/m² every 8 weeks during 2 years
Also known as: Mabthera
Progression-free survival
Progression-free survival is defined as the time from randomization to the first occurrence of disease progression, relapse or death from any cause; using iwCLL criteria
Time frame: randomization until disease progression or death
Event-free survival
Event-free survival is defined as the time from randomization to the occurrence of one of the following events, whichever occurs first: disease progression or relapse, death from any cause, initiation of any new anti-CLL therapy, and secondary malignancy
Time frame: randomization until disease progression, death, new CLL treatment, and secondary cancer
Disease-free survival
Disease-free survival is defined as the time from first documented CR to relapse
Time frame: first documented CR until relapse
Overall survival
Overall survival is defined as the time from randomization to death from any cause
Time frame: randomization until death
Time to next treatment
Time to next treatment is defined as the time from randomization to initiation of a new CLL-related treatment
Time frame: randomization until new CLL treatment
Overall response rate
Overall response rate is defined by the percentage of participants with an overall response; CR or PR according to NCI criteria and CR, CRi or PR according to iwCLL
Time frame: baseline up to approximately 66 months
Phenotypic response rate
Phenotypic response rate is defined by the percentage of participants with minimal residual disease negativity as measured by six-colour flow cytometry with a sensitivity of 0.7 x 10-5. MRD is considered as undetectable when the positivity criteria, defined as the presence of at least 20 CLL cells, is not reached
Time frame: randomization up to approximately 60 months
Rates of treatment-related adverse events
Rate of treatment-related adverse events (plus adverse events of particular interest) is defined as the percentage of participants with adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and version 2.0. for hematological toxicity
Time frame: safety since baseline
Pharmacokinetics of rituximab
Pharmacokinetics of rituximab during induction and rituximab maintenance
Time frame: baseline up to approximately 36 months
Quality of life
Change from baseline in EORTC Quality of Life Questionnaire Core 30
Time frame: baseline up to approximately 30 months
Plan to share: No
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Tours