Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia

The primary objective of the trial is to determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with chemotherapy (FLA) in children with relapsed or refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemia based on safety and pharmacokinetics (PK).

Trial Details

NCT ID
NCT06376162
Phase
PHASE1
Sponsor
PedAL BCU, LLC
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Ziftomenib
  • Cytarabine
  • Fludarabine
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Age: 0-21 years (and at least 5 kg body weight), with a minimum of 80% of participants under 18 years of age.
  • Diagnosis: KMT2A-r, NPM1-m, or NUP98-r acute leukemia in first or greater relapse or refractory to standard (re-) induction treatment (including HS…
  • Eligible participants also must fulfill one of the following conditions:
  • First or subsequent relapse:

For full eligibility, visit ClinicalTrials.gov.

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