Clinical trial · Observational
Autoimmune Cytopenia and BcR Inhibitors
Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated With Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)
NCT03469895CI-TRIAL-00032123CABRIunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated with Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)
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 |
|---|---|---|---|
| Autoimmune Cytopenia Associated With Chronic Lymphocytic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ibrutinib ou idelalisib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- active CLL treated with ibrutinib or idelalisib for CAI
- description
- Patient with CLL Active autoimmune cytopenia Initiation of a treatment with ibrutinib or idelalisib for autoimmune cytopenia. The progressive nature of contemporary CAI LLC is not a criterion of exclusion.
- interventionNames
- Drug: ibrutinib ou idelalisib
Primary outcomes (1)
- measure
- Efficacy of B-cell receptor inhibitors on autoimmune cytopenia (AIC)
- timeFrame
- 1 year
- description
- Regarding autoimmune cytopenias, the responses to treatments were defined as such: Complete answer * hemoglobin level\> 120 g/l without transfusion * AND platelet count\> 100 G/l * AND reticulocytes \<100 G/l * AND normal LDH level Partial answer * hemoglobin \<120 g/l but with a gain of 2 g/l, without transfusion * OR hemoglobin\> 120 g/l with reticulocytes\> 100 G/l and or high LDH * OR hemoglobin\> 120 g/l with reticulocytes and / or LDH levels not available * AND OR platelet count between 50 and 100 G/l
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with CLL * Active autoimmune cytopenia * Initiation of a treatment with ibrutinib or idelalisib for autoimmune cytopenia. Exclusion Criteria: * Other lymphoid hemopathy B * Absence of documentation of the autoimmunity of cytopenia
References
Publications (16)
- BACKGROUNDHodgson K, Ferrer G, Montserrat E, Moreno C. Chronic lymphocytic leukemia and autoimmunity: a systematic review. Haematologica. 2011 May;96(5):752-61. doi: 10.3324/haematol.2010.036152. Epub 2011 Jan 17. PMID 21242190
- BACKGROUNDDierickx D, Kentos A, Delannoy A. The role of rituximab in adults with warm antibody autoimmune hemolytic anemia. Blood. 2015 May 21;125(21):3223-9. doi: 10.1182/blood-2015-01-588392. Epub 2015 Mar 31. PMID 25827833
- BACKGROUNDD'Arena G, Laurenti L, Capalbo S, D'Arco AM, De Filippi R, Marcacci G, Di Renzo N, Storti S, Califano C, Vigliotti ML, Tarnani M, Ferrara F, Pinto A. Rituximab therapy for chronic lymphocytic leukemia-associated autoimmune hemolytic anemia. Am J Hematol. 2006 Aug;81(8):598-602. doi: 10.1002/ajh.20665. PMID 16823816
- BACKGROUNDReynaud Q, Durieu I, Dutertre M, Ledochowski S, Durupt S, Michallet AS, Vital-Durand D, Lega JC. Efficacy and safety of rituximab in auto-immune hemolytic anemia: A meta-analysis of 21 studies. Autoimmun Rev. 2015 Apr;14(4):304-13. doi: 10.1016/j.autrev.2014.11.014. Epub 2014 Dec 9. PMID 25497766
- BACKGROUNDKaufman M, Limaye SA, Driscoll N, Johnson C, Caramanica A, Lebowicz Y, Patel D, Kohn N, Rai K. A combination of rituximab, cyclophosphamide and dexamethasone effectively treats immune cytopenias of chronic lymphocytic leukemia. Leuk Lymphoma. 2009 Jun;50(6):892-9. doi: 10.1080/10428190902887563. PMID 19391041
- BACKGROUNDRossignol J, Michallet AS, Oberic L, Picard M, Garon A, Willekens C, Dulery R, Leleu X, Cazin B, Ysebaert L. Rituximab-cyclophosphamide-dexamethasone combination in the management of autoimmune cytopenias associated with chronic lymphocytic leukemia. Leukemia. 2011 Mar;25(3):473-8. doi: 10.1038/leu.2010.278. Epub 2010 Dec 3. PMID 21127498
- BACKGROUNDQuinquenel A, Willekens C, Dupuis J, Royer B, Ysebaert L, De Guibert S, Michallet AS, Feugier P, Guieze R, Levy V, Delmer A. Bendamustine and rituximab combination in the management of chronic lymphocytic leukemia-associated autoimmune hemolytic anemia: a multicentric retrospective study of the French CLL intergroup (GCFLLC/MW and GOELAMS). Am J Hematol. 2015 Mar;90(3):204-7. doi: 10.1002/ajh.23909. Epub 2015 Jan 16.