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

Neurofibromatosis 1 Clinical Trial

Official title:
Risk Stratified Treatment for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia: A Phase I/II Non-randomized Study of Trametinib and Azacitidine With or Without Chemotherapy (IND #164058)

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

Clinical Trial Details
NCT number NCT05849662
Study type Interventional
Source Therapeutic Advances in Childhood Leukemia Consortium
Contact
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date November 30, 2023
Completion date December 2029
View Details
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