Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study

Completed

• Conditions: Hairy-cell Leukemia
• Interventions: Other: Data collection

• Registration Number: NCT02883946
• Lead Sponsor: CHU de Reims

Brief Summary

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%.

Detailed Description

Aims of the study were :

* to assess the overall efficacy of rituximab in a cohort of unselected patients with hairy-cell leukemia

* to identify factors associated to treatment response, to duration of treatment response and to patient survival in a cohort of unselected patients with hairy-cell leukemia

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-02
• Study Completion: 2014-06
• Status Verified: 2016-08
• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-08-25
• Last Update Submitted: 2016-08-25
• Study First Posted: 2016-08-30
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hairy-cell leukemia	Data collection	Patients with hairy-cell leukemia.

Primary Outcome Measures

Name	Time	Method
Complete hematologic response to rituximab therapy	Month 6	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

Trial Locations

Locations (1)

Chu de Reims; 🇫🇷 Reims, France