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NCT05360160 · ClinicalTrials.gov registry record · Phase 1

A Phase I-II Study Investigating the All-Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)

A Phase 1 study of Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
43
Enrollment target
1
Study location

NCT05360160: Recruiting Phase 1 study of Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.

NCT05360160 is a Phase 1 study of Acute Myeloid Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 43 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05360160, a Phase 1 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
43 participants
Enrollment target
1
Study location

Study Summary

Part 1b of this clinical research study is to find the highest tolerable dose of SNDX-5613 that can be given in combination with ASTX727 (a combination of the drugs decitabine/cedazuridine) and venetoclax for patients with acute myeloid leukemia (AML) or those with a mixed phenotype acute leukemia with a myeloid phenotype (MPAL). Part 2 of this study is to learn if the dose of study drugs found in Part 1b can help to control AML/MPAL

Conditions Studied

Interventions

  • DRUG Venetoclax
  • DRUG ASTX727
  • DRUG SNDX-5613

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2022-10-14
Est. Completion 2026-12-01
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What NCT05360160 shows while recruiting

NCT05360160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (63% lower).

The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.

NCT05360160 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT05360160 about?

NCT05360160 is a clinical study titled "A Phase I-II Study Investigating the All-Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)". Part 1b of this clinical research study is to find the highest tolerable dose of SNDX-5613 that can be given in combination with ASTX727 (a combination of the drugs decitabine/cedazuridine) and venetoclax for patients with acute myeloid leukemia (AML) or those with a mixed phenotype acute leukemia w...

What is the current status of trial NCT05360160?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2022-10-14. Estimated completion is 2026-12-01.

What conditions does trial NCT05360160 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia.

What interventions are being tested in trial NCT05360160?

The interventions under investigation include: Venetoclax (DRUG), ASTX727 (DRUG), SNDX-5613 (DRUG).

Who is sponsoring clinical trial NCT05360160?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05360160 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05360160's enrollment target sits among peer trials

43 166th of 306 higher than 140 of 306 other Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05360160, the US trial registry maintained by the National Library of Medicine. NCT05360160 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.