Clinical Trial: Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Brief Summary:

The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle of cladribine in patients with hairy cell leukemia requiring treatment.

They have to be untreated so far or may be pretreated with alpha-interferon.


Detailed Summary:

Evaluation of remission status will take place 4 months after treatment. In addition, it will be tested whether patients with non-optimal response will have a benefit from a second cycle of cladribine.

Non-optimal response is: patients with detectable residual disease; achievement of partial remission or detectable residual infiltration in the bone marrow.


Sponsor: University of Giessen

Current Primary Outcome: Determination of the rate of complete remissions after one cycle with subcutaneous cladribine [ Time Frame: 4 months after treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Rate of complete remissions in patient who still have detectable residual disease [ Time Frame: 4 months after treatment ]

A second cycle of cladribine after an interval of 4 months following the first cycle.


Original Secondary Outcome: Same as current

Information By: University of Giessen

Dates:
Date Received: April 30, 2014
Date Started: May 2004
Date Completion: December 2027
Last Updated: October 25, 2016
Last Verified: October 2016