Clinical trial · Interventional
Rituximab Maintenance Versus Observation After First-line Immunochemotherapy by FCR in Older Patients With Chronic Lymphocytic Leukemia
Single-agent Rituximab as Maintenance Treatment Versus Observation After Combined Induction Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients Older Than 65 Years With Previously Untreated Chronic Lymphocytic Leukemia: a Phase III Trial of FILO
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Observation
- description
- Observation every 8 weeks during 2 years
- type
- EXPERIMENTAL
- label
- rituximab arm
- description
- rituximab :500 mg/m² every 8 weeks during 2 years
- interventionNames
- Biological: Rituximab
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- randomization until disease progression or death
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDartigeas C, Van Den Neste E, Leger J, Maisonneuve H, Berthou C, Dilhuydy MS, De Guibert S, Lepretre S, Bene MC, Nguyen-Khac F, Letestu R, Cymbalista F, Rodon P, Aurran-Schleinitz T, Vilque JP, Tournilhac O, Mahe B, Laribi K, Michallet AS, Delmer A, Feugier P, Levy V, Delepine R, Colombat P, Leblond V; CLL 2007 SA investigators; French Innovative Leukemia Organization (FILO). Rituximab maintenance versus observation following abbreviated induction with chemoimmunotherapy in elderly patients with previously untreated chronic lymphocytic leukaemia (CLL 2007 SA): an open-label, randomised phase 3 study. Lancet Haematol. 2018 Feb;5(2):e82-e94. doi: 10.1016/S2352-3026(17)30235-1. Epub 2017 Dec 20. PMID 29275118