Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

This is a research study to find out if adding a new study drug called revumenib to commonly used chemotherapy drugs is safe and if they have beneficial effects in treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that did not go into remission after treatment (refractory) or has come back after treatment (relapsed), and to determine the total dose of the 3-drug combination of revumenib, azacitidine and venetoclax that can be given safely in participants also taking an anti-fungal drug. Primary Objective * To determine the safety and tolerabili

Trial Details

NCT ID
NCT06177067
Phase
PHASE1
Sponsor
St. Jude Children's Research Hospital
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Revumenib
  • Venetoclax
  • Azacitidine
  • intrathecal (IT) chemotherapy
  • Cytarabine
  • Methotrexate
Locations (sample)
  • San Diego, California, United States|32.71571,-117.16472
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Kansas City, Missouri, United States|39.09973,-94.57857
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Refractory leukemia, defined as persistent leukemia after at least two courses of induction chemotherapy (one course for secondary AML), or relapse…
  • However, if an adequate bone marrow sample cannot be obtained (e.g., in a patient with acute megakaryoblastic leukemia with marrow fibrosis), patie…
  • Presence of KMT2A rearrangement (KMT2Ar), NUP98 rearrangement (NUP98r), NPM1 mutation or fusion, PICALM::MLLT10, DEK::NUP214, UBTF-TD, KAT6A rearra…
  • Adequate organ function, defined as total bilirubin \< 1.5 × institutional upper limit of normal for age or normal conjugated bilirubin (for patien…

For full eligibility, visit ClinicalTrials.gov.

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