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AzTrials

Leukemia, Myeloid, AcutePhase 2NCT06384261

A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy

A Phase 2 study testing Cusatuzumab, Venetoclax and Azacitidine in people with Leukemia, Myeloid, Acute, run by OncoVerity, Inc. at 38 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia (AML) compared to venetoclax and azacitidine. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
Cusatuzumab, Venetoclax and Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
38 sitesin 5 countries
Study dates
22 Jul 2024to Jun 2027
Phase
Phase 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

  • 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:
  • Participant is ≥75 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 OR
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  • Participant is ≥18 to 74 years of age and has any of the following comorbidities:
  • ECOG performance status of 2 or 3
  • Cardiac status including any one of the following: congestive heart failure requiring treatment or ejection fraction ≤50% or chronic stable angina
  • Known history of diffusion capacity of lung for carbon monoxide (DLCO) ≤65% of forced expiratory volume in the first second (FEV1) ≤65%
  • Creatinine clearance (CrCl) ≥15 mL/min to <45 mL/min
  • Hepatic disorder with total bilirubin >1.5 to 3x the upper limit of normal (ULN)
  • Any other comorbidity that the investigators determine to be incompatible with conventional intensive chemotherapy
  • Adequate liver and renal function defined as:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3xULN; for participants with leukemic infiltration of the liver (documented by biopsy or imaging), AST and ALT <5xULN is permitted
  • Total bilirubin ≤1.5xULN, unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin. Participants who are <75 years of age may have a bilirubin up to 3xULN.
  • Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease [MDRD] formula). Participants who are <75 years of age may have an eGFR ≥15 mL/min/1.73 m2.
  • 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
  • WOCBP must agree to adhere to the following birth control measures while receiving study treatment continuing to 3 months after the last dose of study drug:
  • Must be practicing a highly effective method of birth control (failure rate of <1% per year when used consistently and correctly) as determined by institutional standards
  • Must agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction
  • Must not be breastfeeding and not planning to become pregnant
  • Male participants who are sexually active with WOCBP, and male partners of study participants who are WOCBP, and who are not surgically or otherwise sterile must agree to adhere to the following birth control measures while receiving study treatment and for 3 months after the last dose of study drug:
  • Must agree to use a barrier method of birth control (e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam, gel, film, cream, or suppository)
  • Must not donate sperm
  • Must no plan to father a child
  • Participants with HIV infection are eligible for the trial if the following criteria are met:
  • CD4+ T-cell count ≥200 cells/μL
  • No prior history of AIDS-defining opportunistic infection within the past 12 months
  • Receiving treatment with antiretroviral therapy
  • Undetectable viral load within 6 months of screening

Who cannot join

  • 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.
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  • 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:
  • Nonmelanoma skin cancer treated within the last 24 months that is considered completely cured
  • Adequately treated breast lobular carcinoma in situ and breast ductal carcinoma in situ
  • Adequately treated cervical carcinoma in situ and breast ductal carcinoma in situ
  • History of localized breast cancer and receiving anti-hormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen depravation therapy
  • A malignancy that is considered cured with minimal risk of recurrence
  • 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:
  • Seropositivity for hepatitis B is defined by a positive test for hepatitis B surface antigen (HBsAg)
  • Participants with resolved infection (i.e., participants who are HBsAg negative with antibodies to total hepatitis B core antigen [anti-HBc] with or without the presence of hepatitis B surface antibody [anti-HBs]) must be screened using PCR measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded.
  • 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
  • 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

Trial locations and contacts

38 sites in 5 countries.

38 sites in 5 countries

United States20 sites

  • University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Cleveland Clinic - Taussig Cancer Institute

    Cleveland, Ohio, 44195

  • City of Hope

    Duarte, California, 91010

  • Banner MD Anderson

    Gilbert, Arizona, 85234

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • Hofstra/Northwell Health

    Lake Success, New York, 11042

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Norton Healthcare, Inc.

    Louisville, Kentucky, 40202

  • University of Miami - Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

  • Medical College of Wisonsin

    Milwaukee, Wisconsin, 53226

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • Cornell University

    New York, New York, 10065

  • AdventHealth Medical Group Blood &amp; Marrow Transplant at Orlando

    Orlando, Florida, 32804

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Fred Hutch Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of South Florida = Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Wake Forest North Carolina

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada7 sites

  • Tom Baker Cancer Center-Alberta Health Services - University of Calgary

    Calgary, Alberta, T2N 4N2

  • Stollery Children's Hospital-Walter C Mackenzie Health Sciences Centre - University of Alberta

    Edmonton, Alberta, T6G 2B7

  • University of Western Ontario

    London, Ontario, N6A5W9

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H8L6

  • Saskatchewan Cancer Agency - Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N4H4

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5F 2M9

  • Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Spain5 sites

  • Hospital De La Santa

    Barcelona

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    Barcelona

  • Vall d'Hebron Institute of Oncology

    Barcelona

  • Universidad de Navarra - Clinica Universidad de Navarra

    Pamplona

  • Hospital Universitario de Salamanca

    Salamanca

Other trials in Spain

Germany3 sites

  • Marien Hospital Duesseldorf

    Düsseldorf, 40479

  • Universitaetsklinik Frankfurt

    Frankfurt, 60560

  • Universitaetsklinik um Schleswig-Holstein, UKSH-Campus Kiel

    Kiel, 24105

Other trials in Germany

Switzerland3 sites

  • Inselspital Bern

    Bern, 3010

  • HFR Fribourg - Hopital Cantonal

    Fribourg, Switzerland

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

Official title: Multicenter, Open-label, Randomized, Phase 2 Study of Venetoclax and Azacitidine Plus Cusatuzumab Versus Venetoclax and Azacitidine Alone in Newly Diagnosed AML Patients Who Are Not Candidates for Intensive Therapy

The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia (AML) compared to venetoclax and azacitidine. Venetoclax and azacitidine are drugs commonly used to treat AML in patients that are unable to receive chemotherapy to treat AML. The main question the clinical trial aims to answer is does cusatuzumab added to venetoclax and azacitidine prolong the length of time participants live compared to venetoclax and azacitidine?

Read the detailed description

This is a randomized, open-label, multicenter, Phase 2 trial to evaluate the efficacy, safety, and pharmacodynamics of cusatuzumab in combination with venetoclax and azacitidine (VAC) compared to venetoclax and azacitidine (VA) in persons with newly diagnosed AML who are deemed ineligible for intensive chemotherapy. The trial will be conducted in 2 Parts. Part A will seek to randomize approximately 120 participants 2:1 to receive VAC or VA. Randomized participants will be stratified based on AML risk features (adverse, intermediate, and favorable risk). Part B will seek to include approximately 20 participants to receive an alternative dose of cusatuzumab in combination with VA in a non-randomized fashion.

Parts A and B will utilize the same eligibility criteria, study assessments, and treatment guidelines and procedures unless otherwise specified. Potential participants will be considered ineligible for intensive chemotherapy and, therefore, eligible for the study, if they meet the trial eligibility criteria and provide informed consent. Participants will undergo a diagnostic bone marrow biopsy and aspirate collected for pathology review, cytogenetics, fluorescence in situ hybridization (FISH), and polymerase chain reaction (PCR) analysis and other studies for confirmation of a diagnosis of AML and to define whether participants have adverse, intermediate, or favorable AML risk features.

Being tested
Cusatuzumab, Venetoclax, Azacitidine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • CusatuzumabDrug

    Also called OV-1001

    CD70 monoclonal antibody

  • VenetoclaxDrug

    BCL-2 inhibitor

  • AzacitidineDrug

    Hypomethylating agent

Study groups in NCT06384261
Study groupRoleWhat they receive
Part A: Cusatuzumab in combination with venetoclax and azacitidineExperimentalCusatuzumab 20 mg/kg administered intravenously on days 3 and 17 in combination with venetoclax administered orally up to 400 mg once daily and azacitidine 75 mg/m^2 administered subcutaneously or intravenously once daily for 7 days of a 28 day cycle
Receives: Drug: Cusatuzumab; Drug: Venetoclax; Drug: Azacitidine
Part A: Venetoclax in combination with azacitidineActive comparatorVenetoclax administered orally up to 400 mg once daily and azacitidine 75 mg/m^2 administered subcutaneously or intravenously once daily for 7 days of a 28 day cycle
Receives: Drug: Venetoclax; Drug: Azacitidine
Part B: Cusatuzumab in combination with venetoclax and azacitidineExperimentalCusatuzumab 10 mg/kg administered intravenously on days 3 and 17 for cycle 1 and cycle 2 and 20 mg/kg intravenously on days 3 and 17 for cycle 3 and beyond in combination with venetoclax administered orally up to 400 mg once daily and azacitidine 75 mg/m^2 administered subcutaneously or intravenously once daily for 7 days of a 28 day cycle
Receives: Drug: Cusatuzumab; Drug: Venetoclax; Drug: Azacitidine

What is being measured

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

  1. Overall survival

    In all randomized participants

    Measured: From date of randomization until the date of death from any cause, assessed up to 5 years

Secondary outcomes (15)

  1. Complete Remission rate (CR)

    Proportion of participants achieving CR per the European LeukemiaNet (ELN) 2022 criteria

    Measured: From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years

  2. Event-free survival (EFS)

    Defined per ELN 2022 criteria

    Measured: From date of randomization to date of treatment failure, hematologic relapse from CR/CRh/CRi or death from any cause, assessed up to 5 years

  3. Composite CR rate (CRc)

    Sum of CR+CRh+CRi rate. CRh is defined as CR with partial hematologic recovery. CRi is defined as CR with incomplete hematologic recovery. Defined per ELN 2022 criteria.

    Measured: From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years

  4. Rate of CRh and CRi

    Defined per ELN 2022 criteria

    Measured: From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years

  5. Duration of CR

    Defined per ELN 2022 criteria

    Measured: From date of first CR to hematological relapse or death from any cause, assessed up to 5 years

  6. Time to first CR

    Defined per ELN 2022 criteria

    Measured: From date of randomization to first occurrence of CR, assessed up to 3 years

  7. Rate of minimal residual disease (MRD) negativity in patients achieving CR, CRh, or CRi

    Defined per ELN 2022 criteria and guidelines for testing

    Measured: From date of randomization to relapse or criteria for refractory disease are met, assessed up to 5 years

  8. Proportion of participants proceeding to hematopoietic stem cell transplantation (HSCT)

    Measured: From date of randomization to date of HSCT, assessed up to 5 years

  9. OS in participants undergoing HSCT

    Measured: From date of randomization to death from any cause, assessed up to 5 years

  10. Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation

    Per CTCAE criteria

    Measured: Signing of informed consent to 30 days after the last dose of study treatment or until start of subsequent anti-AML therapy

  11. Incidence of dose modifications due to AEs

    Includes interruptions and/or delays

    Measured: Randomization to 30 days after the last dose of study treatment or until start of subsequent anti-AML therapy

  12. Number of participants with abnormal laboratory test results

    Findings will be summarized

    Measured: Signing of informed consent to 30 days after the last dose of study treatment or until start of subsequent anti-AML therapy

  13. Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)

    Measured: From date of randomization to end of treatment, assessed up to 5 years

  14. Overall survival in subgroups of participants according to specified AML risk stratification models

    Measured: From date of randomization to death from any cause, assessed up to 5 years

  15. Complete Remission rate

    In subgroups of participants according to specified AML risk stratification models. CR defined per ELN 2022 criteria.

    Measured: From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2024
  2. Study start22 Jul 2024
  3. Primary completionJan 2027 (estimated)
  4. Study completionJun 2027 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06384261
Sponsor's protocol ID
OV-AML-1231
Other IDs
2024-510991-19-00
Status last verified
May 2026
First submitted
18 Apr 2024
Last updated
11 May 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 2 study testing Cusatuzumab, Venetoclax and Azacitidine in people with Leukemia, Myeloid, Acute, run by OncoVerity, Inc. at 38 sites in 5 countries.

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 32 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Canada, Spain, Germany, Switzerland. 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 phase mean?

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: From date of randomization until the date of death from any cause, assessed up to 5 years). 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 NCT06384261.

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 11 May 2026.

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