Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia
Categories (click each to see list of all clinical trials associated with that category): Leukemia/MDS/MPD (ONC)
Current Status: Open
Phase: I (Cancer Control)
Principal Investigator: Haddadin, Michael
Contact Information:
Penny Hardiman, RN
402-559-4135
penny.hardiman@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06001788?term=NCT06001788&rank=1
Summary
Primary
To determine the safety and tolerability of each protocol-specified ziftomenib combination in patients with KMT2A-r or NPM1-m (± co-occurring FLT3-m) R/R AML
Secondary
To evaluate the antileukemic response for ziftomenib combinations in patients with KMT2A-r or NPM1-m (± co-occurring FLT3-m) R/R AML based on the ELN 2022
To evaluate survival and disease control outcomes for protocol-specified ziftomenib combinations in patients with KMT2A-r or NPM1-m (± co-occurring FLT3-m) R/R AML
To characterize the PK of ziftomenib and metabolites when administered in combination with SOC treatments in adults with R/R NPM1-m or KMT2A-r AML
To evaluate the PK of gilteritinib when administered concurrently with ziftomenib in adults with R/R NPM1-m (+ co-occurring FLT3-m)
Exploratory
To evaluate biomarkers related to the biology of AML and their potential correlation to efficacy and resistance to ziftomenib combined with SOC treatments
To evaluate pharmacodynamic biomarkers potentially related to the activity of ziftomenib combined with SOC treatments in adults with R/R AML with NPM1-m (± co-occurring FLT3 mutation) or KMT2A-r