Clinical trial · Observational
Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study
- 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)
Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs, cladribine and pentostatin, which have shown similar efficacy and constitute the gold standard of care either as front-line therapy or for relapsed patients. However, despite the remarkable response rates obtained with purine analogs therapy, some patients will eventually relapse and the efficacy of these agents seems to decrease at each line of treatment. The addition of new molecules to purine analogs may improve the response rates and prevent relapse. Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20 molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years ago and several series of patients treated with rituximab as monotherapy were published in the following decade, reporting response rates ranging from 25% to 80%.
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 |
|---|---|---|---|
| Hairy-cell Leukemia | Hairy Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- hairy-cell leukemia
- description
- Patients with hairy-cell leukemia.
- interventionNames
- Other: Data collection
Primary outcomes (1)
- measure
- Complete hematologic response to rituximab therapy
- timeFrame
- Month 6
- description
- Complete hematologic response was defined as * the recovery of normal blood counts (absolute neutrophil count ≥ 1.5x109/L, platelet count ≥ 100x109/L and hemoglobin level ≥ 120g/L for men and ≥ 110g/L for women) * the absence of circulating cells of hairy-cell leukemia and clinical signs of hairy-cell leukemia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with hairy-cell leukemia diagnosed between July 2002 and September 2012 * patients had received at least 3 subsequent injections of rituximab * aged \> 18 years
References
Publications (1)
- BACKGROUNDLeclerc M, Suarez F, Noel MP, Vekhoff A, Troussard X, Claisse JF, Thieblemont C, Maloisel F, Beguin Y, Tamburini J, Barbe C, Delmer A. Rituximab therapy for hairy cell leukemia: a retrospective study of 41 cases. Ann Hematol. 2015 Jan;94(1):89-95. doi: 10.1007/s00277-014-2175-0. Epub 2014 Sep 7. PMID 25195120