NCT05849662View on ClinicalTrials.gov

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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

October 11, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2029

Conditions
Leukemia, Juvenile MyelomonocyticJMMLJCMLNeurofibromatosis 1CBL Syndrome
Interventions
DRUG

Trametinib

"PO or NG QD Days 1-28~For patients age \< 6 years: 0.032 mg/kg/day at max dose = 2mg/day~For patients age ≥ 6 years: 0.025 mg/kg/day at max dose = 2 mg/day"

DRUG

Azacitidine

"IV over 30 minutes Days 1-5~Age \< 1 year or weight \<10kg:~2.5 mg/kg/day~Age ≥ 1 year and weight ≥ 10kg:~75 mg/m2/day"

DRUG

Fludarabine

"IV over 30 minutes Days 6-10~30 mg/m2/day (1mg/kg if \<12 kg)"

DRUG

Cytarabine

"IV over 3 hours Days 6-10~2000 mg/m2/day (67mg/kg if \<12 kg)"

Trial Locations (4)

20010

RECRUITING

Children's National Medical Center, Washington D.C.

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

94158

RECRUITING

University of California San Francisco, San Francisco

900027

RECRUITING

Children's Hospital Los Angeles, Los Angeles

All Listed Sponsors
lead

Therapeutic Advances in Childhood Leukemia Consortium

OTHER