A Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination with Gilteritinib in Subjects with Relapsed/Refractory Acute Myeloid Leukemia.
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
To assess the safety, tolerability and efficacy for the combination of venetoclax and gilteritinib in patients with relapsed/refractory AML.
Adults who are at least 18 years old and not responded to standard treatment for AML. Patients with APL (acute promyelocytic leukemia), BCR-ABL-positive leukemia, active CNS leukemia, chronic New York Heart Association class IV heart failure, chronic respiratory disease that requires continuous oxygen use, active infection with HIV, Hepatitis B or Hepatitis C are not eligible. All female subjects of childbearing potential must have a negative pregnancy test in order to participate and must be willing to use an effective form of contraception for a minimum of 6 months following the last dose of study drug whereas sexually active male subjects should practice effective methods of contraception from the start of the study to at least 4 months after the last dose of study drug. All subjects must meet all entry criteria to be eligible to participate.
There are two parts to this study. In the first part of dose escalation phase, a dose combination of venetoclax and gilteritinib will be orally administered in increasing doses until tolerated to determine the fixed combination dose. Second part is the dose expansion phase where the fixed combination dose will be studied to evaluate the safety and effectiveness of study drug. Most of the subjects will be hospitalized for about the first week of study drug administration. Venetoclax will be administered from day 2 and Gilteritinib from day 1 of 28 day - Cycle 1. And then, both the drugs are administered daily for 28-day Cycle 2 and beyond.
01/19/2020 05:03 AM