Rituximab in Treating Patients With Refractory or Recurrent Hairy Cell Leukemia Following Cladribine Therapy
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|ClinicalTrials.gov Identifier: NCT00003757|
Recruitment Status : Completed
First Posted : April 30, 2003
Last Update Posted : May 15, 2012
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|
- 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)|
|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|
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 ClinicalTrials.gov identifier (NCT number): NCT00003757
|Zurich, Switzerland, CH-8008|
|Study Chair:||Albert von Rohr, MD||Klinik Hirslanden, Zurich|