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

Study Overview
=================
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.

Official Title
-----------------
Rituximab (IDEC-C2B8, Mabthera) in Patients With Hairy Cell Leukemia Relapsing After Treatment With 2-Chlorodeoxyadenosine (CDA)

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Biological: rituximab


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: rituximab|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
progressive hairy cell leukemia, initial treatment, refractory hairy cell leukemia