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ADVENT-AML: Azacitidine, Venetoclax, and NK Cells for AML

This study is testing if adding healthy donor natural killer (NK) cells to the standard combination of Azacitidine and Venetoclax can help control Acute Myeloid Leukemia (AML). NK cells are a type of immune cell that fights cancer. You may be able to join if you are 18 or older, have a confirmed diagnosis of AML or MDS/AML, and have relapsed or refractory (R/R) disease where standard treatments are no longer effective. The main goal is to see how safe this combination treatment is. Researchers will also look at how many people respond to the treatment and how long they live without their cancer returning. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 32 participants. It is a Phase Ib trial, meaning it's an early-stage study focused on safety.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured through study completion, which is 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.

NCT05834244

A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~32 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:AzacitidineVenetoclaxNK Cells

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured over Through study completion; an average of 1 year

Conditions

Acute Myeloid Leukemia

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Where it's being run

2 sites across 2 states
Ohio1
Texas1

Study leadership

  • Abhishek Maiti, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Abhishek Maiti, MD
[email protected]
713-792-7305
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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. 13. 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. 14. 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 treatment. 15. Ability to understand and the willingness to sign a written informed consent document.

What this trial measures

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0Through study completion; an average of 1 year