Study of Cusatuzumab with Venetoclax and Azacitidine for AML
This study is testing if adding cusatuzumab to venetoclax and azacitidine helps people with newly diagnosed acute myeloid leukemia (AML) live longer. AML is a type of blood cancer. Venetoclax and azacitidine are common treatments for AML when intensive chemotherapy isn't an option. The study wants to see if the combination of all three drugs works better than venetoclax and azacitidine alone. You might be able to join if you are 18 or older, have newly diagnosed AML, and cannot receive intensive chemotherapy. The study is currently recruiting participants.
- Study design
- This is a randomized, open-label, multicenter Phase 2 study with approximately 140 participants. Participants will be assigned by chance (randomized) to one of the treatment groups.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your overall survival will be measured from the start of the study until death, for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06384261
A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentOncoVerity, Inc.
~140 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:CusatuzumabVenetoclaxAzacitidine
At a glance
Recruiting sites
0 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival
Measured over From date of randomization until the date of death from any cause, assessed up to 5 years
Conditions
Where it's being run
38 sites across 21 statesSpain5
Florida3
New York3
Ontario3
Germany3
Switzerland3
California2
Kentucky2
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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.
Eligibility criteria
Inclusion
Men and women ≥18 years old
Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study
Diagnosis of AML according to ICC 2022 (with the exclusion of MDS/AML with 10-19% blasts)
Previously untreated AML except may have received emergency leukapheresis, hydroxyurea before study entry to control hyperleukocytosis
Deemed unfit for intensive chemotherapy by meeting at least 1 of the following criteria:
Adequate liver and renal function defined as:
Women of childbearing potential (WOCBP), defined as fertile women between menarche and post menopause unless permanently sterile, must have a negative highly sensitive serum β-human chorionic gonadotropin (β-hCG) or urine pregnancy test at screening
Must be willing to use contraception as consistent with institutional guidelines regarding the use of contraceptive methods for participants participating in clinical studies
Participants with HIV infection are eligible for the trial if the following criteria are met:
Exclusion
Any prior treatment for AML (except those outlined in inclusion criterion #4)
Participant has received a hypomethylating agent (HMA) or venetoclax for MDS or myeloproliferative neoplasm
Leukemic involvement in the central nervous system
Participants with acute promyelocytic leukemia (APL)
ECOG performance status of 4 for participants 18 to 74 years of age and ECOG performance status of 3 or 4 for participants ≥75 years of age
Use of immune suppressive agents ≤4 weeks before the first administration of cusatuzumab. Participants may be included if free of systemic corticosteroids \>5 days before the first administration of cusatuzumab with the exception of corticosteroids at physiologic replacement doses.
Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug
Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Exceptions to this exclusion criterion include the following:
Any active systemic infection
History of prior HSCT (allogeneic or autologous transplants)
Active hepatitis B or C infection or other clinically active liver diseases ad defined below:
Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR 3. Active hepatitis C infection as defined by being positive for a nucleic acid test for hepatitis C virus (HCV) RNA
Congestive hear failure severity that is New York Heart Association Class III or IV
Unstable angina
Known allergies, hypersensitivity, or intolerance to cusatuzumab, venetoclax, or azacitidine or their excipients (e.g., mannitol, an excipient of azacitidine)
Inability or difficulty swallowing capsules/tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function
Any condition for which, in the investigator's opinion, participation would not be in the best interest of the participant (e.g., compromise the well-being) or physical limitations that could prevent, limit, or confound the protocol-specified assessments
Major surgery (e.g., requiring general anesthesia) ≤4 weeks prior to initiation of study treatment
What this trial measures
- Overall survivalFrom date of randomization until the date of death from any cause, assessed up to 5 years
In all randomized participants