B Cell Lymphomas Clinical Trial
Official title:
A Two-part Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumour Activity of Multiple Ascending Doses of AZD6738 in Patients With Relapsed/Refractory B Cell Malignancies With Expansion to Patients With Prospectively Identified 11q-deleted or ATM-deficient, Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL)
In Part A to investigate the safety and tolerability of AZD6738 when given orally to
patients with relapsed/refractory CLL, PLL or B cell lymphoma.
In Part B to investigate the safety and tolerability of AZD6738 when given orally to
patients with prospectively identified 11q deleted or ATM deficient, relapsed/refractory CLL
In this first time in patient study, AZD6738 will be administered to patients with
relapsed/refractory chronic lymphocytic leukaemia (CLL), prolymphocytic leukaemia (PLL) or B
cell lymphomas, primarily to determine the safety and tolerability of AZD6738.
Pharmacokinetics of AZD6738 and potential biological activity will also be investigated.
An oral formulation of AZD6738 will be used. The starting dose of 20 mg twice daily (BD)
will be escalated to reach a maximum tolerated dose in patients as defined by dose-limiting
toxicity. A '3 week on, 1 week off' schedule, as deemed optimal in modelling of data from
non-clinical studies, will be used initially.
Following the dose escalation phase of the study, additional patients with prospectively
identified 11q-deleted or ATM deficient relapsed/refractory CLL will be enrolled to a dose
expansion phase to explore further the safety, tolerability, pharmacokinetics and biological
activity at selected dose(s)/schedule(s).
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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