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

August 25, 2016 updated by: CHU de Reims

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%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU de Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with hairy-cell leukemia.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hairy-cell leukemia
Patients with hairy-cell leukemia.
Other: Data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete hematologic response to rituximab therapy
Time Frame: 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
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015Ao007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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