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AMLPhase 1/2NCT07508982

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

A Phase 1/2 study testing Azacitidine and APG1252 in people with AML, 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

This is a phase Ib/II study that aims to investigate the safety, tolerability and explore the efficacy of BCL- XL inhibition in participants with high-risk AML. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AML
What is being tested?
Azacitidine and APG1252
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
22 May 2026to 12 Dec 2031
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Part I, Lead-in phase and Part II, Cohort A:
  • Patients with relapsed and/or refractory AML Patients with high-risk MDS/AML who have had prior therapy will also be included
  • Part II, Cohort B
  • Patients with untreated, newly diagnosed AML of the following subtypes:
  • 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
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  • AML with MECOM rearrangement, including, but not limited to t(3;3), inv(3q), confirmed by conventional karyotype or FISH for MECOM rearrangement.
  • 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.
  • Adequate organ function as defined below:
  • Liver function (bilirubin < 2mg/dL, AST and ALT <3 x ULN - or ≤5 x ULN if related to leukemic involvement) Kidney function (estimated creatinine clearance > 50 mL/min). Known cardiac ejection fraction of > or = 45% within the past 3 months
  • ECOG performance status of ≤ 2.
  • A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
  • Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
  • The effects of APG1252 on the developing human fetus are unknown. For this reason and because BCL-2/BCL-XL inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
  • 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.
  • Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of APG1252 administration. Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Pregnant women are excluded from this study because the agent used in this study has the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
  • 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.
  • 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.
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  • Patient with documented hypersensitivity to any of the components of the therapy program.
  • Patients with known active, uncontrolled CNS leukemia will not be eligible.
  • Patients with prior treatment with a BCL-XL inhibitor will not be eligible.
  • 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.
  • Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies) unless HIV RNA is undetectable by PCR.
  • 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.

Trial locations and contacts

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

Tapan Kadia, MD contact

(713) 563-3534

tkadia@mdanderson.org

United States1 site, 1 recruiting

  • UT MD Anderson

    Houston, Texas, 77030

    Tapan Kadia, MD

    Tapan Kadia, MD

    Recruiting

Other trials in United States

About this study

This is a phase Ib/II study that aims to investigate the safety, tolerability and explore the efficacy of BCL- XL inhibition in participants with high-risk AML.

Read the detailed description

Primary Objectives:

Phase Ib: To evaluate the safety, tolerability, and maximum tolerated dose of APG1252 in combination with Azacitidine in patients with relapsed or refractory (R/R) high-risk Acute Myeloid Leukemia (AML)

Phase II: To evaluate the initial efficacy information in terms of ORR (CR/CRi/MLFS).

Secondary Objectives:

  • [Phase Ib] To evaluate response (complete response [CR] including complete response without blood count recovery [CRi] or marrow leukemia free state [MLFS]) of APG1252 in combination with Azacitidine
  • [Phase Ib and Phase II] To evaluate the event free survival of APG1252 in combination with Azacitidine in patients with high-risk AML
  • [Phase Ib and Phase II] To assess the time to response, response duration, relapse-free survival, and overall survival (OS) in patients with AML treated with APG1252 in combination with Azacitidine

Although the clinical benefit of this drug has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability.

Conditions
AML
Being tested
Azacitidine, APG1252

What participants receive

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

  • AzacitidineDrug

    Also called Vidaza, Onureg

    Given by IV

  • APG1252Drug

    Also called Pelcitoclax

    Given by IV

Study groups in NCT07508982
Study groupRoleWhat they receive
Cohort A: Part II Cohort A Treatment with Azacitidine (IV or SQ) + APG1252 (IV) Q4W R/R AMLExperimentalTreatment will be administered on an inpatient or outpatient basis. All induction and consolidation intravenous infusions of APG-1252 will be administered at MD Anderson Cancer Center (MDACC).
Receives: Drug: Azacitidine; Drug: APG1252
Cohort B: Part II Cohort B Treatment with Azacitidine (IV or SQ)+APG1252 (IV) Q4W untreated AMLExperimentalTreatment will be administered on an inpatient or outpatient basis. All induction and consolidation intravenous infusions of APG-1252 will be administered at MD Anderson Cancer Center (MDACC).
Receives: Drug: Azacitidine; Drug: APG1252
Lead-In: Part I Lead-In Treatment with Azacitidine (IV or SQ) + APG1252 (IV) Q4W R/R AMLExperimentalTreatment will be administered on an inpatient or outpatient basis. All induction and consolidation intravenous infusions of APG-1252 will be administered at MD Anderson Cancer Center (MDACC).
Receives: Drug: Azacitidine; Drug: APG1252

What is being measured

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

  1. Safety and Adverse Events (AEs)

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

    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 posted3 Apr 2026
  2. Study start22 May 2026
  3. Primary completion12 Dec 2029 (estimated)
  4. Study completion12 Dec 2031 (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
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07508982
Sponsor's protocol ID
2025-1579
Other IDs
NCI-2026-02429
Status last verified
Sep 2026
First submitted
30 Mar 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Azacitidine and APG1252 in people with AML, 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 20 inclusion and 12 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 5 Oct 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 Tapan Kadia, MD ((713) 563-3534, tkadia@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Adverse Events (AEs) (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 NCT07508982.

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 5 Oct 2026.

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