Rituximab in Treating Patients With Refractory or Recurrent Hairy Cell Leukemia Following Cladribine Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003757
Recruitment Status : Completed
First Posted : April 30, 2003
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy consisting of rituximab in treating patients with refractory or recurrent hairy cell leukemia following cladribine therapy.

Condition or disease Intervention/treatment Phase
Leukemia Biological: rituximab Phase 2

Detailed Description:


  • Determine the rate of complete and partial remission, remission duration, and relapse free survival after treatment with rituximab in patients with refractory or recurrent hairy cell leukemia who previously received cladribine.
  • Determine the acute and long term toxicity of rituximab in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive rituximab IV over several hours once a week for 4 weeks.

Patients are followed every 3 months for 3 years and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 8-25 patients will be accrued for this study within 3 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rituximab (IDEC-C2B8, Mabthera) in Patients With Hairy Cell Leukemia Relapsing After Treatment With 2-Chlorodeoxyadenosine (CDA)
Study Start Date : February 1998
Actual Primary Completion Date : July 2002
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Rituximab
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven hairy cell leukemia (HCL)

    • Classic HCL

      • Hairy cells in the bone marrow and/or peripheral blood which co-express CD20/CD25 or CD20/CD11c, and/or which are positive for tartrate resistant acid phophatase (TRAP)
    • Prolymphocytic HCL variant

      • Lymphoid cells in the bone marrow and/or peripheral blood with morphology intermediate between typical hairy cells and prolymphocytes, which co-express CD20/CD11c but lack CD25 expression, and which are negative for TRAP
  • Progressive or recurrent disease after prior treatment with cladribine

    • Greater than 1 month since standard dose cladribine OR
    • Greater than 3 months since low dose cladribine



  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months


  • Not specified


  • Bilirubin no greater than 2.0 mg/dL


  • Creatinine no greater than 2.3 mg/dL


  • No serious cardiac disease


  • No acute or chronic infection
  • HIV negative
  • No psychosis
  • Not pregnant or nursing
  • No other prior or concurrent malignancy except carcinoma in situ of the cervix or basal cell or squamous cell skin cancer


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • Recovered from prior chemotherapy

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • Recovered from prior therapy
  • No concurrent cytoreductive therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003757

Klinik Hirslanden
Zurich, Switzerland, CH-8008
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Study Chair: Albert von Rohr, MD Klinik Hirslanden, Zurich

Publications of Results:
Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00003757     History of Changes
Other Study ID Numbers: SAKK 31/98
First Posted: April 30, 2003    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Swiss Group for Clinical Cancer Research:
progressive hairy cell leukemia, initial treatment
refractory hairy cell leukemia

Additional relevant MeSH terms:
Leukemia, Hairy Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents