NCT02131753

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Hairy Cell Leukemia

Interventions

Type	Name	Description
DRUG	Cladribine s.c. injection, HCL treatment	Patients with hairy cell leukemia and the need for treatment are given cladribine 0.14 mg/kg for 5 consecutive days as a s. c bolus injection

Timeline

• Start date: 2004-05-01
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2014-05-06
• Last updated: 2024-08-22

Locations

76 sites across 1 country: Germany