Clinical Trial: Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Study on the Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia
Brief Summary:
The study will test the effectiveness (rate of complete remissions, total remission rate and duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous cladribine (LITAK®) plus anti-CD20* antibody rituximab in patients requiring treatment for relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous therapy.
CD20* = cluster of differentiation antigen 20
Detailed Summary: The trial is a prospective, multi-centre, open Phase II study on patients with hairy cell leukaemia variant or with relapsed hairy cell leukaemia.
Sponsor: Jurgen Barth
Current Primary Outcome: Rate of complete remissions (CR) [ Time Frame: 4 months after treatment ]
Determination of the rate of complete remission and duration of remission after one cycle of subcutaneous cladribine (LITAK®) plus four administrations of rituximab
- in patients with hairy cell leukaemia variant
- in patients with relapsed hairy cell leukaemia
Original Primary Outcome: Same as current
Current Secondary Outcome: Overall remission rate (ORR) [ Time Frame: 4 months after treatment ]
Original Secondary Outcome: Same as current
Information By: University of Giessen
Dates:
Date Received: May 21, 2014
Date Started: June 2004
Date Completion:
Last Updated: June 3, 2014
Last Verified: June 2014