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

May 7, 2026 updated by: OncoVerity, Inc.

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center-Alberta Health Services - University of Calgary
      • Edmonton, Alberta, Canada, T6G 2B7
        • Stollery Children's Hospital-Walter C Mackenzie Health Sciences Centre - University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre
    • Ontario
      • London, Ontario, Canada, N6A5W9
        • University of Western Ontario
      • Ottawa, Ontario, Canada, K1H8L6
        • The Ottawa Hospital - General Campus
      • Toronto, Ontario, Canada, M5F 2M9
        • Princess Margaret Cancer Centre
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N4H4
        • Saskatchewan Cancer Agency - Saskatoon Cancer Centre
  • Germany
      • Düsseldorf, Germany, 40479
        • Marien Hospital Duesseldorf
      • Frankfurt, Germany, 60560
        • Universitaetsklinik Frankfurt
      • Kiel, Germany, 24105
        • Universitaetsklinik um Schleswig-Holstein, UKSH-Campus Kiel
  • Spain
      • Barcelona, Spain
        • Vall d'Hebron Institute of Oncology
      • Barcelona, Spain
        • Hospital De La Santa
      • Barcelona, Spain
        • Instituto Catalán de Oncología - Hospital Duran i Reynals
      • Pamplona, Spain
        • Universidad de Navarra - Clinica Universidad de Navarra
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital Bern
      • Fribourg, Switzerland, Switzerland
        • HFR Fribourg - Hôpital Cantonal
      • Sankt Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami - Sylvester Comprehensive Cancer Center - Miami
      • Orlando, Florida, United States, 32804
        • AdventHealth Medical Group Blood & Marrow Transplant at Orlando
      • Tampa, Florida, United States, 33612
        • University of South Florida = Moffitt Cancer Center and Research Institute
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • The University of Iowa Hospitals & Clinics
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare, Inc.
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Lake Success, New York, United States, 11042
        • Hofstra/Northwell Health
      • New York, New York, United States, 10065
        • Cornell University
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest North Carolina
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic - Taussig Cancer Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch Seattle Cancer Care Alliance
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisonsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    1. Participant is ≥75 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 OR

    2. Participant is ≥18 to 74 years of age and has any of the following comorbidities:

      1. ECOG performance status of 2 or 3
      2. Cardiac status including any one of the following: congestive heart failure requiring treatment or ejection fraction ≤50% or chronic stable angina
      3. Known history of diffusion capacity of lung for carbon monoxide (DLCO) ≤65% of forced expiratory volume in the first second (FEV1) ≤65%
      4. Creatinine clearance (CrCl) ≥15 mL/min to <45 mL/min
      5. Hepatic disorder with total bilirubin >1.5 to 3x the upper limit of normal (ULN)
      6. Any other comorbidity that the investigators determine to be incompatible with conventional intensive chemotherapy

  • Adequate liver and renal function defined as:

    1. 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
    2. 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.
    3. 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

    1. 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:

      1. 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
      2. Must agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction
      3. Must not be breastfeeding and not planning to become pregnant

    2. 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:

      1. 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)
      2. Must not donate sperm
      3. Must no plan to father a child

  • Participants with HIV infection are eligible for the trial if the following criteria are met:

    1. CD4+ T-cell count ≥200 cells/μL
    2. No prior history of AIDS-defining opportunistic infection within the past 12 months
    3. Receiving treatment with antiretroviral therapy
    4. Undetectable viral load within 6 months of screening

Exclusion Criteria:

  • 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:

    1. Nonmelanoma skin cancer treated within the last 24 months that is considered completely cured
    2. Adequately treated breast lobular carcinoma in situ and breast ductal carcinoma in situ
    3. Adequately treated cervical carcinoma in situ and breast ductal carcinoma in situ
    4. History of localized breast cancer and receiving anti-hormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen depravation therapy
    5. 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:

    1. Seropositivity for hepatitis B is defined by a positive test for hepatitis B surface antigen (HBsAg)

    2. 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
    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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: Cusatuzumab in combination with venetoclax and azacitidine
Cusatuzumab 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
Drug: Azacitidine
Hypomethylating agent
Drug: Cusatuzumab
CD70 monoclonal antibody
Other Names:
  • OV-1001
Drug: Venetoclax
BCL-2 inhibitor
Active Comparator: Part A: Venetoclax in combination with azacitidine
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
Drug: Azacitidine
Hypomethylating agent
Drug: Venetoclax
BCL-2 inhibitor
Experimental: Part B: Cusatuzumab in combination with venetoclax and azacitidine
Cusatuzumab 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
Drug: Azacitidine
Hypomethylating agent
Drug: Cusatuzumab
CD70 monoclonal antibody
Other Names:
  • OV-1001
Drug: Venetoclax
BCL-2 inhibitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 5 years
In all randomized participants
From date of randomization until the date of death from any cause, assessed up to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Remission rate (CR)
Time Frame: From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years
Proportion of participants achieving CR per the European LeukemiaNet (ELN) 2022 criteria
From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years
Event-free survival (EFS)
Time Frame: 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
Defined per ELN 2022 criteria
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
Composite CR rate (CRc)
Time Frame: From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years
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.
From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years
Rate of CRh and CRi
Time Frame: From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years
Defined per ELN 2022 criteria
From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years
Duration of CR
Time Frame: From date of first CR to hematological relapse or death from any cause, assessed up to 5 years
Defined per ELN 2022 criteria
From date of first CR to hematological relapse or death from any cause, assessed up to 5 years
Time to first CR
Time Frame: From date of randomization to first occurrence of CR, assessed up to 3 years
Defined per ELN 2022 criteria
From date of randomization to first occurrence of CR, assessed up to 3 years
Rate of minimal residual disease (MRD) negativity in patients achieving CR, CRh, or CRi
Time Frame: From date of randomization to relapse or criteria for refractory disease are met, assessed up to 5 years
Defined per ELN 2022 criteria and guidelines for testing
From date of randomization to relapse or criteria for refractory disease are met, assessed up to 5 years
Proportion of participants proceeding to hematopoietic stem cell transplantation (HSCT)
Time Frame: From date of randomization to date of HSCT, assessed up to 5 years
From date of randomization to date of HSCT, assessed up to 5 years
OS in participants undergoing HSCT
Time Frame: From date of randomization to death from any cause, assessed up to 5 years
From date of randomization to death from any cause, assessed up to 5 years
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation
Time Frame: Signing of informed consent to 30 days after the last dose of study treatment or until start of subsequent anti-AML therapy
Per CTCAE criteria
Signing of informed consent to 30 days after the last dose of study treatment or until start of subsequent anti-AML therapy
Incidence of dose modifications due to AEs
Time Frame: Randomization to 30 days after the last dose of study treatment or until start of subsequent anti-AML therapy
Includes interruptions and/or delays
Randomization to 30 days after the last dose of study treatment or until start of subsequent anti-AML therapy
Number of participants with abnormal laboratory test results
Time Frame: Signing of informed consent to 30 days after the last dose of study treatment or until start of subsequent anti-AML therapy
Findings will be summarized
Signing of informed consent to 30 days after the last dose of study treatment or until start of subsequent anti-AML therapy
Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Time Frame: From date of randomization to end of treatment, assessed up to 5 years
From date of randomization to end of treatment, assessed up to 5 years
Overall survival in subgroups of participants according to specified AML risk stratification models
Time Frame: From date of randomization to death from any cause, assessed up to 5 years
From date of randomization to death from any cause, assessed up to 5 years
Complete Remission rate
Time Frame: From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years
In subgroups of participants according to specified AML risk stratification models. CR defined per ELN 2022 criteria.
From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OncoVerity, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OV-AML-1231
  • 2024-510991-19-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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