Who is sponsoring NCT06226571?

NCT06226571 is sponsored by Syndax Pharmaceuticals.

What condition does NCT06226571 study?

NCT06226571 studies Acute Myeloid Leukemias.

What drugs are being tested in NCT06226571?

Interventions: SNDX-5613, Chemotherapy Regimen, HiDAC.

What is the status of NCT06226571?

NCT06226571 is currently RECRUITING.

Last reviewed 2026-02-12 · How we verify

A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes

NCT06226571 Phase 1 RECRUITING

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.

Details

Lead sponsor	Syndax Pharmaceuticals
Phase	Phase 1
Status	RECRUITING
Enrolment	76
Start date	2024-05-21
Completion	2027-02

Conditions

Acute Myeloid Leukemias

Interventions

SNDX-5613
Chemotherapy Regimen
HiDAC

Primary outcomes

Dose Escalation: Number of Participants with Dose-limiting Toxicities — Up to Day 42
Number of Participants with Treatment-emergent Adverse Events (TEAEs) — Day 1 through 30 days after final dose (up to approximately 3 years)

Countries

United States, Australia, Canada, Netherlands, Spain, United Kingdom