PhI/II DFP-10917 in Combo W/ Venetoclax in Relapse/Refractory Acute Myeloid Leukemia
Study Description
This Phase I/II trial evaluates the safety and preliminary efficacy of DFP-10917 combined with venetoclax in relapsed or refractory acute myeloid leukemia. DFP-10917 is given as a 14-day continuous IV infusion every 28 days, alongside a 14-day oral course of venetoclax following an initial dose ramp-up. The initial phase tests a starting dose of 4 mg/m²/day of DFP-10917 with 400 mg daily of venetoclax. The Data Monitoring Committee reviews toxicity after one treatment cycle. If DLTs are minimal, more patients are added to confirm safety. If the lower dose level shows tolerability, it proceeds to the Phase II expansion to assess the treatment's effectiveness against leukemia using a Simon's two-stage design, targeting up to 17 participants.
Eligibility
-Signed informed consent and ability to comply with protocol requirements.
-Labs drawn to confirm your diagnosis
-Labs drawn to check Creatinine ,bilirubin and Alanine aminotransferase levels
-Projected life expectancy of ≥12 weeks.
-Female patients of childbearing potential must:
*Have a negative serum or urine pregnancy test prior to study treatment initiation.
*Agree to use at least 1 highly effective form of contraception during study treatment and for 3 months after the last dose.
-Male patients with female partners of childbearing potential must -- Agree to use at least 1 highly effective form of contraception during study treatment and for at least 3 months after the last dose.
Interested in Participating in this Trial?
Thank you for your interest with our team.
One of our specialists will be in contact with you soon.