PhI/II DFP-10917 in Combo W/ Venetoclax in Relapse/Refractory Acute Myeloid Leukemia

UCI Specialty Area: Cancer

Principal Investigator: Kiran Naqvi

Official Title: Phase I/II Study of DFP-10917 in Combination with Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia

A Study On:

Myeloid and Monocytic 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.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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