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Acute Myeloid LeukemiaPhase 1/2NCT05360160

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 1/2 study testing SNDX-5613, Venetoclax and ASTX727 in people with Acute Myeloid Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
SNDX-5613, Venetoclax and ASTX727
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteUnited States
Study dates
14 Oct 2022to 1 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥ 12 years with weight ≥ 40Kg.
  • ECOG performance status of ≤ 2.
  • Newly diagnosed (frontline cohort), who are not eligible for high-intensity induction chemotherapy or relapsed/refractory (R/R cohort) AML or myeloid phenotype MPAL with either KMT2Ar, or NUP98r, or NPM1c.
  • WBC must be below 25,000/ μL at time of enrollment. Patients may receive cytoreduction prior to enrollment.
  • Baseline ejection fraction must be > 40%.
  • Adequate hepatic function (direct bilirubin < 2x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT < 3x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT < 5x ULN will be considered eligible).
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  • Adequate renal function (creatinine clearance ≥ 30 mL/min) unless related to disease.
  • Willing and able to provide informed consent.
  • In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of the prior therapy. Oral hydroxyurea and/or cytarabine (up to 2 g/m2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the PI. Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted.
  • Women of childbearing potential must agree to adequate methods of contraception during the study and at least 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study and at least 3 months after the last treatment.

Who cannot join

  • Prior treatment with a menin inhibitor.
  • Patients with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.
  • The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea for patients with rapidly proliferative disease or for control of counts during differentiation syndrome. (3) use of steroids for treatment of differentiation syndrome.
  • Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
  • Patients with a concurrent active malignancy under treatment.
  • Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.
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  • Female subjects who are pregnant or breast-feeding.
  • Patient has an active uncontrolled infection.
  • Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.
  • QTc >470 msec using the Fridericia Formula.
  • History of a complete bundle branch block or high-degree atrioventricular block.
  • History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
  • Clinically active central nervous system (CNS) leukemia.
  • Patients on immunosuppressive therapy post-HSCT at the time of screening with R/R leukemia (must be off all systemic immunosuppression therapy for at least 2 weeks and calcineurin inhibitors for at least 4 weeks). The use of topical steroids for cutaneous graftversus- host disease (GVHD) or stable systemic steroid doses less than or equal to 20 mg of prednisone daily are permitted.
  • Patients with Grade > 2 active acute GVHD, moderate or severe limited chronic GVHD, or extensive chronic GVHD of any severity.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ghayas Issa, MD contact

(713) 745-6798

gcissa@mdanderson.org

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Ghayas Issa, MD, 713-745-6798, gcissa@mdanderson.org

    Ghayas Issa, MD

    Recruiting

Other trials in United States

About this study

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)

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

Read the detailed description

Primary Objectives:

Phase Ib

  • To determine the safety, tolerability and recommended phase II dose (RP2D) of SNDX-5613 in combination with oral decitabine/cedazuridine (ASTX727) and venetoclax for patients with acute myeloid leukemia (AML).

Phase II

  • To assess the efficacy of SNDX-5613 in combination with ASTX727 and venetoclax for patients with AML.

Secondary Objectives

  • To assess overall survival, event-free survival and duration of response.

Exploratory Objectives

  • To evaluate molecular and cellular markers that may be predictive of antitumor activity and/or resistance.
Being tested
SNDX-5613, Venetoclax, ASTX727
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SNDX-5613Drug

    Given by PO

  • VenetoclaxDrug

    Given by PO

  • ASTX727Drug

    Given by PO

Study groups in NCT05360160
Study groupRoleWhat they receive
SNDX-5613ExperimentalCapsules by mouth 2 times every day (about 12 hours apart).
Receives: Drug: SNDX-5613
VenetoclaxExperimentalTablets by mouth on Days 1-14 of each cycle.
Receives: Drug: Venetoclax
ASTX727ExperimentalTablets by mouth on Days 1-5 of each cycle.
Receives: Drug: ASTX727

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To establish the recommended phase II dose (RP2D) of SNDX-5613 in combination with oral decitabine/cedazuridine (ASTX727) and venetoclax for patients with acute myeloid leukemia (AML).

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2022
  2. Study start14 Oct 2022
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05360160
Sponsor's protocol ID
2021-1059
Other IDs
NCI-2022-03312
Status last verified
Sep 2026
First submitted
13 Apr 2022
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Issa GC, Cuglievan B, El Hajjar G, Jen WY, Bataller A, Short NJ, DiNardo CD, Alvarado Y, Loghavi S, Duose DY, Zhang B, Furudate K, Ning J, Xiao L, Mouhayar E, Pinto A, Bidikian A, Thompson E, Daver N, Garcia-Manero G, Farhat A, McCall D, Kadia TM, Abbas HA, Tan S, Bazinet A, Jabbour E, Montalban-Bravo G, Ravandi F, Takahashi K, Andreeff M, Kantarjian HM. All-Oral Combination of Revumenib, Decitabine, and Venetoclax for Relapsed or Refractory AML (SAVE). J Clin Oncol. 2026 Aug;44(22):2110-2120. doi: 10.1200/JCO-26-01159. Epub 2026 Jun 11.

    PubMed 42272166

  • Garcia MB, Wang B, Sheikh I, El Hajjar G, McCall D, Nunez C, Gibson A, Lorenzi PL, Issa GC, Cuglievan B, Abbas HA. High-Throughput Proteomic Profiling to Evaluate Differentiation Syndrome With Menin Inhibition. Mol Cell Proteomics. 2026 Mar;25(3):101522. doi: 10.1016/j.mcpro.2026.101522. Epub 2026 Jan 30.

    PubMed 41621809

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SNDX-5613, Venetoclax and ASTX727 in people with Acute Myeloid Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ghayas Issa, MD ((713) 745-6798, gcissa@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To establish the recommended phase II dose (RP2D) of SNDX-5613 in combination with oral decitabine/cedazuridine (ASTX727) and venetoclax for patients with acute myeloid leukemia (AML). (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05360160, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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