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Clinical Trial 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.


Clinical Trial Description

Primary Objectives: 1. To determine the safety of combining trametinib with azacitidine for patients with newly diagnosed lower-risk JMML. 2. To determine the safety of combining trametinib with azacitidine (Aza), fludarabine (FLA) and cytarabine for patients with newly diagnosed high-risk JMML. Dosing: Patients with newly diagnosed lower-risk JMML will be treated with daily azacitidine for 5 days in combination with daily trametinib for 28 days per course for up to 12 courses. Patients with newly diagnosed high-risk JMML will be treated with daily azacitidine, fludarabine, and cytarabine for 5 days in combination with daily trametinib for 28 days per course for up to 2 courses. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05849662
Study type Interventional
Source Therapeutic Advances in Childhood Leukemia Consortium
Contact Ellynore Florendo
Phone 323-361-3022
Email eflorendo@chla.usc.edu
Status Recruiting
Phase Phase 1/Phase 2
Start date May 10, 2024
Completion date December 2029

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