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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 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.

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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

Acute Myeloid Leukemia

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

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05360160

The ClinicalTrials.gov registry entry for NCT05360160 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (63% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.