Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study

Hairy-cell Leukemia Clinical Trial

— RITUX-LEUKEMIA  

Official title:

Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883946
• Other study ID #: 2015Ao007
• Status: Completed
• Phase: N/A
• First received: August 25, 2016
• Last updated: August 25, 2016
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2016
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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%.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hairy-cell Leukemia
• Leukemia
• Leukemia, Hairy Cell

Intervention

Other:
• Data collection

Locations

Country	Name	City	State
France	Chu de Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

References & Publications (1)

Leclerc M, Suarez F, Noël 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete hematologic response to rituximab therapy	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	Month 6	No