Therapy Optimisation for the Treatment of Hairy Cell Leukemia

  • STATUS
    Recruiting
  • End date
    Dec 25, 2027
  • participants needed
    210
  • sponsor
    University of Giessen
Updated on 25 May 2022

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.

Description

Evaluation of remission status will take place 4 months after treatment. In addition, it will be tested whether patients with non-optimal response will have a benefit from a second cycle of cladribine.

Non-optimal response is: patients with detectable residual disease; achievement of partial remission or detectable residual infiltration in the bone marrow.

Details
Condition Hairy Cell Leukemia
Treatment Cladribine s.c. injection, HCL treatment
Clinical Study IdentifierNCT02131753
SponsorUniversity of Giessen
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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