This phase I trial tests the safety, side effects and the dose of oral cladribine that is equivalent to intravenous (IV) cladribine in patients with hairy-cell leukemia (HCL) or T-cell prolymphocytic leukemia (T-PLL). Cladribine is in a class of medications called antimetabolites and is currently given as an infusion into a vein (intravenous). It works by interfering with the normal division and function of cells. The availability of oral cladribine may allow patients to take the medication at home instead of traveling to an office to receive it as an infusion through a vein. The convenience of oral cladribine may help improve the quality of life, limit exposure to infections in a hospital setting and lower healthcare costs in patients with HCL or T-PLL.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06021600.
PRIMARY OBJECTIVE:
I. To identify a dose of oral cladribine that is bioequivalent to IV cladribine when the IV dose is administered via a 2-hour infusion to patients with HCL or T-PLL.
SECONDARY OBJECTIVES:
I. To assess the plasma pharmacokinetics (PK) of oral cladribine following single-dose and multiple dose administration.
II. To identify a dose of oral cladribine that provides comparable exposure (area under the curve [AUC]) to IV cladribine when the IV dose is administered via a 2-hour infusion to patients with HCL or T-PLL.
III. To assess the safety of oral cladribine in patients with HCL or T-PLL.
OUTLINE: Patients are assigned to 1 of 3 cohorts.
COHORT 1 AND 2: Patients receive cladribine orally (PO) on day 1 and cladribine intravenously (IV) over 2 hours on days 2-5 in the absence of disease progression or unacceptable toxicity. Patients also undergo a multigated acquisition (MUGA) scan or echocardiography (ECHO), bone marrow aspirate and biopsy and blood sample collection at screening and throughout study. Additionally, patients who complete treatment may additionally receive a total of 6 doses of cladribine PO over 2 cycles.
COHORT 3: Patients receive cladribine PO once daily (QD) on days 1-5 in the absence of disease progression or unacceptable toxicity. Patients also undergo a MUGA scan or ECHO, bone marrow aspirate and biopsy and blood sample collection at screening and throughout study.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorFarhad Ravandi-Kashani
