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Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab

NCT02157181 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2024-08-22

No results posted yet for this study

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

Conditions

  • Hairy Cell Leukemia (HCL)

Interventions

DRUG

2CdA +/- Rituximab

Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion

Sponsors & Collaborators

  • Jurgen Barth

    lead OTHER

Principal Investigators

  • Mathias J Rummel, Prof. Dr. · Justus-Liebig-University | University Hospital | Medicinal Clinic IV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2012-09-30
Completion
2013-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02157181 on ClinicalTrials.gov