Ireland
--:--IST
Recruiting Phase 2/3

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

NCT02131753 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2/3
Started
2004-05
Last updated
2024-08-22

Condition(s) studied

Hairy Cell Leukemia

Investigational drug(s) / intervention(s)

Cladribine s.c. injection, HCL treatment →

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with histologically verified hairy cell leukemia * Presence of hairy cells in the bone marrow and peripheral blood detected by positive TRAP staining and / or co expression if cell surface antigens cluster of differentiation (CD) 19/CD25 or CD19/CD103 (b-ly7) * No previous cytostatic treatment (splenectomy or interferon treatment are allowed) * Need for treatment * Age at least 18 years old * General state of health according to WHO 0-2 * Current histology, not older than 6 months * Written consent by patient Exclusion Criteria: * Patients not fulfilling inclusion criteria above * Hairy cell leukemia variants (HCL-V): presence of lymphoid cells in bone marrow and / or peripheral blood, which have an intermediate morphology between hairy cells and prolymphocytes (negative TRAP staining and co- expression of CD19/CD103 without CD25 * Pretreatment with purine analogues or other chemotherapeutics * Concomitant corticosteroid therapy * Severe dysfunction of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver, except due to lymphoma (bilirubin \> 2 mg/dl, alkaline phosphatase, glutamate-oxalacetate transaminase and glutamate-pyruvate transaminase \> 2 x upper limit of normal), the kidneys (creatinin \> 2 mg/dl or creatinine clearance \< 50 ml/min), central nervous system diseases including psychoses. * Proven HIV infection * Active Hepatitis * Other florid infections * Anamnesis / diagnosis of other malignant disease (other than non-melanoma associated skin tumours or stage 0 in situ carcinoma of the cervix) * Pregnant or lactating women

Primary outcome measure(s)

  • Determination of the rate of complete remissions after one cycle with subcutaneous cladribine — 4 months after treatment

Trial sites (76)

FacilityCityRegionStatus
Community based hemato-oncology medical office Ansbach Germany Recruiting
Community based hemato-oncology medical office Aschaffenburg Germany Recruiting
Rhön-Saale-Klinik gGmbH Bad Neustadt an der Saale Germany Recruiting
Community based hemato-oncology medical office Berlin Germany Recruiting
Charité - Universitätsmedizin Berlin Berlin Germany Recruiting
Community based hemato-oncology medical office Bremen Germany Recruiting
Community based hemato-oncology medical office Celle Germany Recruiting
Community based hemato-oncology medical office Cottbus Germany Recruiting
Community based hemato-oncology medical office Darmstadt Germany Recruiting
Community based hemato-oncology medical office Dresden Germany Recruiting
Community based hemato-oncology medical office Duisburg Germany Recruiting
Klinik Duisburg-West Duisburg Germany Recruiting
Universitätsklinik Düsseldorf Düsseldorf Germany Recruiting
Community based hemato-oncology medical office Ehingen Germany Recruiting
Community based hemato-oncology medical office Erlangen Germany Recruiting
Community based hemato-oncology medical office Frankfurt Germany Recruiting
Krankenhaus Nordwest Frankfurt Germany Recruiting
Community based hemato-oncology medical office Freiburg im Breisgau Germany Recruiting
Community based hemato-oncology medical office Friedrichshafen Germany Recruiting
Community based hemato-oncology medical office Fürth Germany Recruiting
Community based hemato-oncology medical office Germering Germany Recruiting
Community based hemato-oncology medical office Giessen Germany Recruiting
University Clinic | Medicinal Clinic IV Giessen Germany Recruiting
St.-Marien-Hospital Hagen Germany Recruiting
Community based hemato-oncology medical office Halle Germany Recruiting
Evangelisches Krankenhaus Hamm Germany Recruiting
Community based hemato-oncology medical office Hanau Germany Recruiting
Community based hemato-oncology medical office Heidelberg Germany Recruiting
Community based hemato-oncology medical office Herne Germany Recruiting
Marienkrankenhaus Herne Germany Recruiting
Community based hemato-oncology medical office Homberg (Ohm) Germany Recruiting
Community based hemato-oncology medical office Kaiserslautern Germany Recruiting
Städtisches Klinikum Karlsruhe Germany Recruiting
Community based hemato-oncology medical office Kassel Germany Recruiting
Klinikum Kempten-Oberallgäu Kempten Germany Recruiting
Community based hemato-oncology medical office Koblenz Germany Not Yet Recruiting
Community based hemato-oncology medical office Krefeld Germany Recruiting
Community based hemato-oncology medical office Kronach Germany Recruiting
Community based hemato-oncology medical office Landau Germany Recruiting
Community based hemato-oncology medical office Landshut Germany Recruiting

+ 36 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02131753 on ClinicalTrials.gov ↗ ← All trials in Germany