A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients with Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation
The primary objectives of Phase 1 are: ? To determine the safety, tolerability, MTD, and RP2D of SNDX-5613 in patients with R/R acute leukemia in Arm A, Arm B, Arm C, and Arm D. ? To characterize the PK parameters of SNDX-5613 in Arm A, Arm B, Arm C, and Arm D. The primary objectives of Phase 2 are: ? To evaluate short- and long-term safety and tolerability of SNDX-5613. ? To assess the CR rate (CR+CRh) in adult patients.
Child to Adult
Treatment
CTRC Inpatient
University of Colorado Hospital
Christine Mcmahon, MD
Protocol Number: 22-1050
More information available at ClinicalTrials.gov: NCT04065399
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