A Phase I/II Study of Trametinib and Azacitidine for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia

This clinical trial will test the safety and efficacy of combining trametinib and azacitidine in patients with juvenile myelomonocytic leukemia (JMML). Newly diagnosed lower-risk JMML patients will receive trametinib and azacitidine. High-risk JMML patients will receive trametinib, azacitidine, fludarabine, and cytarabine.

Trial Details

NCT ID
NCT05849662
Phase
PHASE1 / PHASE2
Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Trametinib
  • Azacitidine
  • Fludarabine
  • Cytarabine
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Los Angeles, California, United States|34.05223,-118.24368
  • San Francisco, California, United States|37.77493,-122.41942
  • Denver, Colorado, United States|39.73915,-104.9847
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637

Key Eligibility Criteria

  • Patients must be ≥ 1 month and ≤21 years of age at enrollment.
  • Diagnosis • Patients must meet the 2022 International Consensus Classification criteria for JMML. The diagnosis is made based on the following crit…
  • Clinical and hematologic features (the first 2 features are present in most cases; the last 2 are required):
  • Peripheral blood monocyte count ≥ 1 × 109/L\*

For full eligibility, visit ClinicalTrials.gov.

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