Optimizing treatment for hairy cell leukemia with cladribine injections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

+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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment for Hairy Cell Leukemia Without BRAF Mutation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.