Clinical Trial

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

Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-05-04; most recent amendment 2026-04-10.
Status change: Not Yet Recruiting → Recruiting 2024-05-16
Trial Details
NCT Number NCT05849662
Lead Sponsor Therapeutic Advances in Childhood Leukemia Consortium
Conditions Leukemia, Juvenile Myelomonocytic, JMML, JCML, Neurofibromatosis 1, CBL Syndrome
Enrollment 58 participants
Start Date 2024-10-11
Primary Completion 2028-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-15