Clinical Trial: Rituximab in Treating Patients With Refractory or Recurrent Hairy Cell Leukemia Following Cladribine Therapy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Rituximab (IDEC-C2B8, Mabthera) in Patients With Hairy Cell Leukemia Relapsing After Treatment With 2-Chlorodeoxyadenosine (CDA)
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 Summary:
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.
Sponsor: Swiss Group for Clinical Cancer Research
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Swiss Group for Clinical Cancer Research
Dates:
Date Received: November 1, 1999
Date Started: February 1998
Date Completion:
Last Updated: May 14, 2012
Last Verified: May 2012
