Optimizing treatment for hairy cell leukemia with cladribine injections
Therapy Optimisation for the Treatment of Hairy Cell Leukemia
PHASE2; PHASE3 · University of Giessen · NCT02131753
This study is testing if a single round of cladribine injections can help people with untreated hairy cell leukemia go into remission.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Giessen (other) |
| Locations | 76 sites (Ansbach and 75 other locations) |
| Trial ID | NCT02131753 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of a single cycle of subcutaneous cladribine in patients with untreated hairy cell leukemia. Participants will be assessed for remission status four months post-treatment, and those with non-optimal responses may receive a second cycle of cladribine. The study aims to determine the best treatment approach for patients requiring intervention for this rare blood cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically verified hairy cell leukemia who have not received prior cytostatic treatment.
Not a fit: Patients with hairy cell leukemia variants or those who have been pretreated with purine analogues or other chemotherapeutics may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and less toxic option for patients with hairy cell leukemia.
How similar studies have performed: Previous studies have shown promise with cladribine in treating hairy cell leukemia, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ansbach and 75 other locations
- 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)
- Community based hemato-oncology medical office — Landshut, Germany (RECRUITING)
- Klinikum Leverkusen GmbH — Leverkusen, Germany (RECRUITING)
- St. Marienkrankenhaus — Ludwigshafen, Germany (RECRUITING)
- Community based hemato-oncology medical office — Lüdenscheid, Germany (RECRUITING)
- Universitätsklinik Mainz — Mainz, Germany (RECRUITING)
- Community based hemato-oncology medical office — Marburg, Germany (RECRUITING)
- Community based hemato-oncology medical office — Mönchengladbach, Germany (RECRUITING)
- Community based hemato-oncology medical office — München, Germany (RECRUITING)
- University Clinic Großhadern — München, Germany (RECRUITING)
- Community based hemato-oncology medical office — Neumarkt, Germany (RECRUITING)
+26 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Mathias J Rummel, Prof. Dr. — Justus-Liebig-University | University Hospital | Medicinal Clinic IV
- Study coordinator: Mathias J Rummel, Prof PhD
- Email: mathias.rummel@innere.med.uni-giessen.de
- Phone: +4964198542
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hairy Cell Leukemia, hairy cell leukemia, untreated, cladribine subcutaneous
Last reviewed 2026-05-15 by the Find a Trial editorial team.
Information on this page is for educational purposes and is not medical advice.
Always consult qualified healthcare professionals about clinical trial participation.