Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Launched by UNIVERSITY OF GIESSEN · May 2, 2014

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with hairy cell leukemia, a rare type of blood cancer. The researchers want to see how well a single cycle of cladribine, given as an injection under the skin, works in treating this condition while also monitoring any side effects. The trial is currently recruiting participants who have not undergone previous chemotherapy but may have had treatment with a medication called alpha-interferon.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of hairy cell leukemia, as shown by specific tests. They should also need treatment right now and have a general health status that is stable. Participants will need to provide written consent to join. Throughout the trial, participants will receive close monitoring to ensure their safety and to assess how effective the treatment is. If you or a loved one are considering this trial, it’s important to discuss it with your healthcare provider to understand if it’s a suitable option.

Gender

ALL

Eligibility 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