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Completed

NCT Number: NCT02883946

Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study

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%.

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Key information

Conditions

Hairy-cell Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Hairy Cell Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Reims

Reims, France, 51092

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: RITUX-LEUKEMIA

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 30, 2016
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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