A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias
18 - 75 Years, Male and Female
SNDX-5613-0708 (primary)
NCI-2024-01922
Summary
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.
Objectives
The Dose Escalation portion of this study will identify the maximum tolerated dose, or if
different, the recommended Phase 2 dose of SNDX-5613 to be used in combination with
intensive chemotherapy and in maintenance monotherapy following intensive chemotherapy in
participants with newly diagnosed AML harboring alterations in KMT2A, NPM1, or NUP98
genes.
In the Dose Expansion portion of the study, safety and preliminary efficacy of SNDX-5613
may be explored in expansion cohorts at tolerated dose levels.
In both Dose Escalation and Dose Expansion, the treatment period will consist of an
induction phase (up to 2 cycles), a consolidation phase (up to 4 cycles and could include
hematopoietic stem cell transplant for participants who are transplant eligible and have
an available donor), and a maintenance monotherapy phase with SNDX-5613. The cycle
duration will be 28 days.
Eligibility
- Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria.
- Previously untreated AML and eligible to receive intensive chemotherapy.
- KMT2Ar, NPM1c, or NUP98r mutations identified by local laboratory prior to the first dose of SNDX-5613.
- Eastern Cooperative Oncology Group performance status =2 and =1 if >65 years old .
- Adequate liver, kidney, and cardiac function.
Treatment Sites in Georgia
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