A Phase 1, Open-Label, Sequential Cross-over, Bioavailability/Bioequivalence Study to Compare the Pharmacokinetics of Oral Cladribine With the Reference Listed Drug, Intravenous Cladribine

Description

Objectives:

* To compare the pharmacokinetic (PK) properties of oral cladribine (investigational product) and intravenous (IV) cladribine (reference standard drug) when administered to patients with hairy-cell leukemia (HCL) or T-cell prolymphocytic leukemia (T-PLL).

Primary:

* 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. Area under the curve (AUC) and maximum concentration (Cmax) will be measured and relative exposure of oral and IV cladribine will be assessed based on the geometric mean ratio and associated 90% confidence interval for dose-normalized AUCs and Cmax for oral-to-IV cladribine, as estimated from an appropriate linear mixed effects model.

Secondary:

* To assess the plasma PK of oral cladribine following single-dose and multiple-dose administration.
* To identify a dose of oral cladribine that provides comparable exposure (AUC) to IV cladribine when the IV dose is administered via a 2-hour infusion to patients with HCL or T-PLL.
* To assess the safety of oral cladribine in patients with HCL or T PLL. No formal efficacy evaluations will be performed in this study. All patients will be observed for complete remission (CR), complete remission without minimal residual disease (MRD), partial response (PR), progressive disease (PD) or stable disease (SD) at the end of the study, although response is not a study endpoint.