NCT05849662 is a Phase 1/Phase 2 clinical trial of Trametinib in Leukemia, Juvenile Myelomonocytic, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.

Who is sponsoring NCT05849662?

NCT05849662 is sponsored by Therapeutic Advances in Childhood Leukemia Consortium.

What drugs are being tested in NCT05849662?

Interventions in NCT05849662: Trametinib, Azacitidine, Fludarabine, Cytarabine.

What condition does NCT05849662 study?

NCT05849662 studies Leukemia, Juvenile Myelomonocytic, JMML, JCML, Neurofibromatosis 1, CBL Syndrome.

Is NCT05849662 still recruiting?

NCT05849662 is currently recruiting now. Last updated 10 April 2026.

Last reviewed 2026-04-10 · How we verify

NCT05849662

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Recruiting now Phase 1/Phase 2 Last updated 10 April 2026

What this trial tests

Phase 1/Phase 2 trial testing Trametinib in Leukemia, Juvenile Myelomonocytic in 58 participants. Currently enrolling.

Timeline

11 October 2024

Primary endpoint
1 December 2028

1 December 2029

Quick facts

Lead sponsor	Therapeutic Advances in Childhood Leukemia Consortium
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	11 October 2024
Primary completion	1 December 2028
Estimated completion	1 December 2029
Sites	19 locations across United States

Drugs / interventions tested

Trametinib (trametinib) — full drug profile →
Azacitidine (azacitidine) — full drug profile →
Fludarabine (FLUDARABINE) — full drug profile →
Cytarabine — full drug profile →

Conditions studied

Leukemia, Juvenile Myelomonocytic — all drugs for Leukemia, Juvenile Myelomonocytic →
JMML — all drugs for JMML →
JCML — all drugs for JCML →
Neurofibromatosis 1 — all drugs for Neurofibromatosis 1 →

Sponsor

Therapeutic Advances in Childhood Leukemia Consortium

Who can join

Adults 1 Month to 21, any sex, with Leukemia, Juvenile Myelomonocytic or JMML. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To determine the safety of combining trametinib with azacitidine for patients with newly diagnosed lower-risk JMML.
Time frame: At the end of the evaluation period of Cycle 1 (defined as 28 day cycle of therapy plus 30 days following the last dose of study therapy)
The incidence of dose limiting toxicities (DLTs) after the 1st course of therapy will be measured at different dose levels.
To determine the safety of combining trametinib with azacitidine (Aza), fludarabine (FLA) and cytarabine for patients with newly diagnosed high-risk JMML.
Time frame: At the end of the evaluation period of Cycle 1 (defined as 28 day cycle of therapy plus 30 days following the last dose of study therapy)
The incidence of dose limiting toxicities (DLTs) after the 1st course of therapy will be measured at different dose levels.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

RAS mutations in myeloid malignancies: revisiting old questions with novel insights and therapeutic perspectives.
Alawieh D, Cysique-Foinlan L, Willekens C, Renneville A. · · 2024 · cited 37× · PMID 38658558 · DOI 10.1038/s41408-024-01054-2
Efficacy of the Allosteric MEK Inhibitor Trametinib in Relapsed and Refractory Juvenile Myelomonocytic Leukemia: a Report from the Children's Oncology Group.
Stieglitz E, Lee AG, Angus SP, Davis C, et al · · 2024 · cited 12× · PMID 38867349 · DOI 10.1158/2159-8290.cd-23-1376
Celebrating Ulrik Ringborg: Multi-Omics-Based Patient Stratification for Precision Cancer Treatment.
Teleanu MV, Schneider A, Ball CR, Leber MF, et al · · 2025 · cited 2× · PMID 40427586 · DOI 10.3390/biom15050693
Azacytidine Monotherapy in an Infant With Mosaic NRAS-Driven Juvenile Myelomonocytic Leukemia.
Grenier JM, Tasian SK, Stieglitz E, Abdullaev Z, et al · · 2025 · PMID 40040253 · DOI 10.1002/pbc.31647

Verify or expand the search:

Other trials of Trametinib

Trials testing the same drug.

NCT05275374 — XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation · Phase 1, PHASE2 · not yet recruiting
NCT07110246 — Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas · Phase 2 · recruiting
NCT07010393 — Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study · Phase 4 · not yet recruiting
NCT06962254 — Imatinib and Trametinib for KRAS-mutated Solid Tumor · Phase 1 · recruiting
NCT06119789 — Precision Cancer Therapy in Rare Cancers · Phase 2 · recruiting

Other Therapeutic Advances in Childhood Leukemia Consortium trials

Trials by the same sponsor.

NCT05476770 — Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies · Phase 1 · recruiting
NCT03825367 — Nivolumab in Combination With 5-azacytidine in Childhood Relapsed/Refractory AML · Phase 1, PHASE2 · unknown
NCT03817320 — PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymph · Phase 1, PHASE2 · active not recruiting
NCT03263936 — Epigenetic Reprogramming in Relapse/Refractory AML · Phase 1 · completed
NCT02879643 — Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05849662 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Therapeutic Advances in Childhood Leukemia Consortium
Last refreshed: 10 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05849662.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing