Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study

NCT ID: NCT02883946

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-06-30

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

Conditions

Hairy-cell Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

hairy-cell leukemia

Patients with hairy-cell leukemia.

Data collection

Intervention Type: OTHER

Interventions

Data collection

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu de Reims

Reims, France, France

Countries

France

References

Leclerc 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.

Reference Type: BACKGROUND

PMID: 25195120 (View on PubMed)

Other Identifiers

2015Ao007

Identifier Type: -

Identifier Source: org_study_id