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OncoMatch/Clinical Trials/NCT02131753

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Is NCT02131753 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies Cladribine s.c. for hairy cell leukemia.

Phase 2/3RecruitingUniversity of GiessenNCT02131753Data as of May 2026

Treatment: Cladribine s.c.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.

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Extracted eligibility criteria

Cancer type

Hairy Cell Leukemia

Performance status

WHO 0–2

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: purine analogues

Pretreatment with purine analogues or other chemotherapeutics

Cannot have received: cytostatic chemotherapy

No previous cytostatic treatment

Cannot have received: other chemotherapeutics

Pretreatment with purine analogues or other chemotherapeutics

Lab requirements

Kidney function

creatinin > 2 mg/dl or creatinine clearance < 50 ml/min

Liver function

bilirubin > 2 mg/dl, alkaline phosphatase, glutamate-oxalacetate transaminase and glutamate-pyruvate transaminase > 2 x upper limit of normal

Cardiac function

severe dysfunction of the heart (NYHA III or IV)

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)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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