Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study (RITUX-LEUKEMIA)

CHU de Reims

Status: Completed

Conditions: Hairy-cell Leukemia

Treatments: Other: Data collection

Study type: Observational

Funder types: Other

Identifiers

NCT02883946

2015Ao007

Details and patient eligibility

About

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%.

Full 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

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

41 participants in 1 patient group

hairy-cell leukemia

Description:

Patients with hairy-cell leukemia.

Treatment:

Other: Data collection