Actively Recruiting

Phase 1
Phase 2
Age: 12Years +
All Genders
Healthy Volunteers
NCT05360160

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)

Led by M.D. Anderson Cancer Center · Updated on 2026-04-14

43

Participants Needed

1

Research Sites

215 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

A

Astex Pharmaceuticals, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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)

Who Can Participate

Age: 12Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 12 years or older weighing at least 40 kg
  • ECOG performance status of 0, 1, or 2
  • Newly diagnosed AML patients not eligible for high-intensity chemotherapy or relapsed/refractory AML or myeloid phenotype MPAL with KMT2Ar, NUP98r, or NPM1c
  • White blood cell count less than 25,000 per microliter at enrollment (cytoreduction allowed before enrollment)
  • Baseline heart ejection fraction over 40%
  • Adequate liver function: direct bilirubin less than 2 times upper normal limit unless caused by Gilbert's disease or leukemia involvement; AST and ALT less than 3 times upper normal limit unless due to leukemia involvement (then less than 5 times)
  • Adequate kidney function with creatinine clearance at least 30 mL/min unless related to disease
  • Ability and willingness to provide informed consent
  • At least 14 days since prior cytotoxic or non-cytotoxic treatment or 5 half-lives of prior therapy unless rapidly proliferative disease (hydroxyurea or cytarabine allowed before study start)
  • Women of childbearing potential and males must agree to use effective contraception during and for 3 months after treatment
Not Eligible

You will not qualify if you...

  • Prior treatment with any menin inhibitor
  • Uncontrolled medical conditions, lab abnormalities, or psychiatric illness posing unacceptable risk
  • Use of other chemotherapy or anti-leukemic agents except intrathecal chemotherapy for CNS prophylaxis/control, hydroxyurea for rapidly proliferative disease, or steroids for differentiation syndrome
  • Severe gastrointestinal or metabolic conditions affecting oral drug absorption
  • Active concurrent cancer under treatment
  • Known active hepatitis B, hepatitis C, or HIV infection
  • Pregnant or breastfeeding females
  • Active uncontrolled infection
  • Certain serious heart conditions or events within 6 months before study entry
  • QTc interval greater than 470 msec
  • History of complete bundle branch block or high-degree atrioventricular block
  • Conditions or therapies that may interfere with study participation or results
  • Clinically active CNS leukemia
  • Immunosuppressive therapy post-stem cell transplant at screening unless off systemic immunosuppression for required durations
  • Grade higher than 2 active acute graft-versus-host disease or moderate/severe limited or extensive chronic graft-versus-host disease

AI-Screening

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

G

Ghayas Issa, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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