Conditions: Acute Myelogenous Leukemia
Keywords: equal to or greater than age 60 years non-M3 AML relapsed disease primary refractory disease not appropriate or willing candidates for aggressive therapy AML
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 27
Healthy volunteers: no

Brief summary:
This was initially a phase I/II, open-label non-randomized study using an investigational new drug, TL32711, in patients with AML, MDS and ALL, however, the phase II portion was never initiated. This study initially targeted subjects 60 years of age and older (with non-M3 AML who have relapsed or refractory disease after standard therapy or who are newly diagnosed and subjects 18-59 (relapsed or refractory after failing 3 prior lines of therapy), and then targeted subjects 18 years of age and older with MDS and ALL.

Detailed description:
This was initially a phase I/II, open-label, non-randomized study using an investigational new drug, TL 32711, in patients with acute myelogenous leukemia. This study targeted subjects 60 years of age and older (with non-M3 AML who have relapsed or refractory disease after standard therapy or who are newly diagnosed and not candidates for standard induction therapy) and subjects 18-59 (relapsed or refractory after failing 3 prior lines of therapy). Subjects would receive the study drug in 4 weeks dosing periods via one of three different treatment schedules (once weekly, twice weekly or three times weekly dosing). They would receive treatment for up to 6 cycles, however treatment may have been extended at the discretion of the study doctor if felt to be in the best interest of the subject. Up to 46 subjects were to be enrolled on this study at the University of Pennsylvania, depending on the number of subjects needed in the Phase I component in order to determine the MTD. The primary objective of the Phase 1 component was to determine the safety and tolerability of TL32711, and the MTD in this patient population. The primary objective of the Phase 2 portion of this study was to further define the safety and tolerability, and provide preliminary efficacy data, however, the Phase II portion was never initiated.

Arms:
arm 1: 26mg/m2/dose IV once per week x 3 weeks of 4 week cycle arm 2: 17mg/m2 IV/dose once per week x 3 weeks of 4 week cycle arm 3: 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle arm 4: 17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle arm 5: 22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle arm 6: 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle

Interventions: intervention 1: Birinapant
Intervention descriptions: intervention 1: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion

Protocol document: