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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00003757
First received: November 1, 1999
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Leukemia
 Biological: rituximab
 Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Rituximab (IDEC-C2B8, Mabthera) in Patients With Hairy Cell Leukemia Relapsing After Treatment With 2-Chlorodeoxyadenosine (CDA)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia
U.S. FDA Resources

Further study details as provided by Swiss Group for Clinical Cancer Research:

Estimated Enrollment: 25
Study Start Date: February 1998
Study Completion Date: July 2007
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL

Renal:

  • Creatinine no greater than 2.3 mg/dL

Cardiovascular:

  • No serious cardiac disease

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • Recovered from prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • Recovered from prior therapy
  • No concurrent cytoreductive therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003757

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

Publications:

Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00003757     History of Changes
Other Study ID Numbers: SAKK 31/98, SWS-SAKK-31/98, EU-98073
Study First Received: November 1, 1999
Last Updated: May 14, 2012
Health Authority: Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on May 16, 2013