OncoMatch/Clinical Trials/NCT05849662
A Phase I/II Study of Trametinib and Azacitidine for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia
Is NCT05849662 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Trametinib and Azacitidine for leukemia, juvenile myelomonocytic.
Treatment: Trametinib · Azacitidine · Fludarabine · Cytarabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: PTPN11 somatic mutation
Somatic mutation in PTPN11
Required: KRAS somatic mutation
Somatic mutation in KRAS
Required: NRAS somatic mutation
Somatic mutation in NRAS
Required: RRAS somatic mutation
Somatic mutation in RRAS
Required: RRAS2 somatic mutation
Somatic mutation in RRAS2
Required: NF1 germline mutation and loss of heterozygosity or somatic biallelic loss
Clinical diagnosis of neurofibromatosis type 1 or germline NF1 mutation and loss of heterozygosity of NF1 or somatic biallelic loss of NF1
Required: CBL germline mutation and loss of heterozygosity or somatic mutation(s)
Germline CBL mutation and loss of heterozygosity of CBL, or somatic mutation(s) in CBL
Required: BCR fusion not detected
Absence of BCR::ABL1
Required: ABL1 fusion not detected
Absence of BCR::ABL1
Prior therapy
Cannot have received: leukemia directed therapy
Exception: hydroxyurea up to 24h prior, 6-mercaptopurine up to 72h prior, intrathecal cytarabine/methotrexate/triple it within 7 days for diagnostic evaluation
Cannot have received: hematopoietic stem cell transplant
Cannot have received: hematopoietic growth factors
Cannot have received: biologics (anti-neoplastic agent)
Cannot have received: radiation therapy
Cannot have received: mek inhibitor
Lab requirements
Kidney function
Calculated creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73m2 OR a normal serum creatinine based on age/gender.
Liver function
Direct bilirubin < 1.5 x ULN for age or normal, AND ALT < 5 x ULN for age. Hepatic requirements waived for patients with known or suspected liver involvement by leukemia (must be approved by study chair/vice chair).
Cardiac function
Ejection fraction ≥ 50% by echocardiogram or radionuclide angiogram (MUGA).
Adequate Renal Function... Adequate Liver Function... Adequate Cardiac Function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital Los Angeles · Los Angeles, California
- University of California San Francisco · San Francisco, California
- Children's National Medical Center · Washington D.C., District of Columbia
- Cincinnati Children's Hospital Medical Center · Cincinnati, Ohio
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