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

NCT ID: NCT00003757

Last Updated: 2012-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-02-28
• Study Completion Date: 2007-07-31

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.

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.

Conditions

Leukemia

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

rituximab

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albert von Rohr, MD

Role: STUDY_CHAIR

Klinik Hirslanden, Zurich

Locations

Klinik Hirslanden

Zurich, , Switzerland

Countries

Switzerland

References

Zenhausern R, Simcock M, Gratwohl A, Hess U, Bargetzi M, Tobler A; Swiss Group for Clinical Cancer Research (SAKK). Rituximab in patients with hairy cell leukemia relapsing after treatment with 2-chlorodeoxyadenosine (SAKK 31/98). Haematologica. 2008 Sep;93(9):1426-8. doi: 10.3324/haematol.11564. Epub 2008 Jul 4. No abstract available.

Reference Type: RESULT

PMID: 18603561 (View on PubMed)

Other Identifiers

SWS-SAKK-31/98

Identifier Type: -

Identifier Source: secondary_id

EU-98073

Identifier Type: -

Identifier Source: secondary_id

SAKK 31/98

Identifier Type: -

Identifier Source: org_study_id