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 ]

The rate of CR + PR will be determined


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