Actively Recruiting
A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)
Led by M.D. Anderson Cancer Center · Updated on 2026-03-11
32
Participants Needed
2
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if adding a healthy person's natural killer (NK) cells to the combination of Azacitidine and Venetoclax can help to control AML. NK cells are cancer- and infection-fighting immune cells.
CONDITIONS
Official Title
A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of AML or MDS/AML with 10% to 19% blasts per current classification
- Age 18 years or older for dose escalation cohort with relapsed/refractory AML or MDS/AML without standard treatment options
- Early first relapse patients with remission duration of 12 months or less eligible in dose escalation cohort
- Patients relapsing after allogeneic stem cell transplant may participate if recovered and off immunosuppression with no more than grade 1 chronic GVHD
- Patients with actionable mutations may enroll after exhausting FDA-approved treatments
- Dose expansion cohort includes older or unfit patients with newly diagnosed adverse or intermediate risk AML or MDS/AML ineligible for intensive chemotherapy or stem cell transplant
- Adequate liver and kidney function as specified
- Willingness to use effective contraception during and after study participation
- Ability to understand and sign informed consent
You will not qualify if you...
- Diagnosis with t(15;17), t(8;21), inv(16), or t(16;16) karyotypic abnormalities
- White blood cell count above 15 x 10⁹/L (supportive care with hydroxyurea or cytarabine allowed)
- Recent high-dose steroid or immunosuppressive therapy within 1 week or 5 half-lives before NK cell infusion
- Known symptomatic or uncontrolled central nervous system leukemia
- Active systemic infections without improvement despite treatment
- Recent CNS pathology or bleeding within specified time frames
- Severe gastrointestinal or metabolic conditions interfering with oral drug absorption
- Uncontrolled heart failure or significant arrhythmia
- Active hepatitis B, hepatitis C, or HIV infection
- Prolonged QT interval or history of Torsades de pointes
- Other medical, psychological, or social conditions interfering with participation or safety
- Recent major surgery or unhealed major wounds
- Legal protection measures or uncontrolled psychiatric conditions
- Hypersensitivity to study drugs or components
- Nursing women or women of childbearing potential with positive pregnancy test or unwillingness to use contraception
- Pregnant or breastfeeding women due to risks of study agents
- Weight less than 50 kg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
2
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Abhishek Maiti, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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