Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study

NCT02883946 | Completed

• 1 other identifier: 2015Ao007
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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%.

Conditions

Hairy-cell Leukemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

hairy-cell leukemia

Patients with hairy-cell leukemia.

Other: Data collection

Interventions

Data collection OTHER

hairy-cell leukemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hairy-cell leukemia.

You may qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

Location

Related Publications (1)

• 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.

  PMID: 25195120 BACKGROUND

MeSH Terms

Conditions

Leukemia, Hairy Cell

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: June 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2014
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

FR (1)