A Phase I-II Open Label Non-Randomized Study Using TL32711 for Patients With Acute Myelogenous Leukemia, Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia
This is a phase I/II, open-label, non-randomized study using an investigational new drug, TL
32711, in patients with acute myelogenous leukemia. This study will target 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 will
receive treatment for up to 6 cycles, however treatment may be extended at the discretion of
the study doctor if felt to be in the best interest of the subject. Up to 46 subjects will
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 of this study is 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 is further define the safety and tolerability, and provide preliminary
efficacy data.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Adverse Events
Yes
United States: Food and Drug Administration
UPCC 15411
NCT01486784
November 2011
December 2014
Name | Location |
---|---|
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |