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Phase 1b/2 Study of AZA + APG1252 for High-Risk AML

This study is testing two drugs, Azacitidine and APG1252, for people with high-risk Acute Myeloid Leukemia (AML), a type of blood cancer. It's a Phase 1b/2 study, meaning it first checks the safety and best dose of APG1252 when given with Azacitidine, and then looks at how well this combination works. You might be able to join if you have AML that has come back or hasn't responded to previous treatment, or if you have newly diagnosed AML of specific subtypes. The study aims to see if the treatment can lead to a complete response (when signs of cancer disappear) or improve survival. The current status of the study is unclear, and it plans to enroll 52 participants.

Study design
This is a Phase 1b/2 interventional study that will enroll 52 participants. It is designed to first evaluate safety and then explore how well the treatment works.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be monitored throughout the study, for an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07508982

Phase1b/2 Trial Of AZA + APG1252 In Patients With High-Risk AML

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~52 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:AzacitidineAPG1252

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year.

Conditions

AML

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic SyndromeMECOM Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Tapan Kadia, MD · PRINCIPAL_INVESTIGATOR · UT MD Anderson

Who to contact

Tapan Kadia, MD
[email protected]
(713) 563-3534
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

AML-M6 or AML-M7 by FAB or having erythroid or megakaryocytic differentiation by WHO 2022 classification
High-risk MDS/AML with erythroid differentiation and no prior therapy
AML with MECOM rearrangement, including, but not limited to t(3;3), inv(3q), confirmed by conventional karyotype or FISH for MECOM rearrangement. 3. Age \>/= 18 years. Because no dosing or adverse event data are currently available on the use of APG1252 in combination with AZA in patients \<18 years of age, children are not included in this study at this time. 4. Adequate organ function as defined below:
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.

Exclusion

Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure. 2. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 3. Patient with documented hypersensitivity to any of the components of the therapy program. 4. Patients with known active, uncontrolled CNS leukemia will not be eligible. 5. Patients with prior treatment with a BCL-XL inhibitor will not be eligible. 6. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. 7. Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies) unless HIV RNA is undetectable by PCR. 8. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation. Hepatitis B virus DNA and HCV RNA must be undetectable upon testing. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (ie, hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility and tests do not need to be repeated. Subjects with prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0