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Leukemia, Myeloid, AcutePhase 1ELEVATENCT04150887

Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia

A Phase 1 study testing Cusatuzumab, Azacitidine and Venetoclax in people with Leukemia, Myeloid, Acute, run by OncoVerity, Inc. at 23 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 purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (AML). 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, Azacitidine and Venetoclax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
23 sitesin 5 countries
Study dates
23 Dec 2019to 15 May 2027
Phase
Phase 1
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

  • Diagnosis of acute myeloid leukemia (AML) according to World Health Organization 2016 criteria . Participants with acute promyelocytic leukemia (APL) are not eligible
  • Must be ineligible for intensive chemotherapy
  • De novo or secondary AML
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Previously untreated AML except: emergency leukapheresis, hydroxyurea, and/or 1 dose 1-2 gram per meter square (g/m^2) cytarabine during the Screening Phase to control hyperleukocytosis. These treatments must be discontinued greater than or equal to (>=) 24 hours prior to start of study drug. Empiric all trans retinoic acid (ATRA) treatment for presumed acute promyelocytic leukemia (APL) is permitted but APL must be ruled out and ATRA must be discontinued >=24 hours prior to the start of study drug
  • Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies

Who cannot join

  • Leukemic involvement of the central nervous system
  • Eligible for an allogeneic hematopoietic stem cell transplantation at study entry
  • Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug
  • A history of human immunodeficiency virus (HIV) antibody positive or tests positive for HIV if tested at screening
  • Known allergies, hypersensitivity, or intolerance to cusatuzumab, venetoclax, azacitidine, or their excipients (example: mannitol, an excipient of azacitidine)

Trial locations and contacts

23 sites in 5 countries.

23 sites in 5 countries

United States11 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14203

  • University of Vermont

    Burlington, Vermont, 05401

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Wisconsin Medical Center

    Milwaukee, Wisconsin, 53226

  • Weill Cornell Medicine

    New York, New York, 10021

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, 15232

  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

Canada4 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • University of Toronto

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany3 sites

  • Universitaetsklinik Hamburg-Eppendorf

    Hamburg, 20246

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Klinikum der Universitaet Muenchen

    München, 81377

Other trials in Germany

Poland3 sites

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

    Lodz, 93-513

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776

Other trials in Poland

Switzerland2 sites

  • INSELSPITAL, Universitätsspital Bern

    Bern, 3010

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

Official title: An Open-label, Multicenter, Phase 1b Study of OV-1001 (Cusatuzumab; Anti-CD70 Monoclonal Antibody) in Combination With Background Therapy for the Treatment of Subjects With Acute Myeloid Leukemia

The purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (AML).

Being tested
Cusatuzumab, Azacitidine, Venetoclax
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 JNJ-74494550, ARGX-110

    Cusatuzumab will be administered as a dose of 10mg/kg or 20mg/kg intravenously.

  • AzacitidineDrug

    Also called Vidaza

    Azacitidine will be administered 75 mg/m^2 subcutaneously or intravenously.

  • VenetoclaxDrug

    Also called Venclexta

    Venetoclax will be administered orally and the dose will ramp-up to 400 mg.

Study groups in NCT04150887
Study groupRoleWhat they receive
Experimental: Cohort 2: Cusatuzumab + VenetoclaxExperimentalParticipants enrolled in this cohort will receive venetoclax ramp-up to 400 mg orally (as background therapy) starting on Cycle 1 Day 1 and followed by 400 mg daily dosing starting on Cycle 1 Day 4 plus cusatuzumab IV on Day 3 and Day 17 of each 28-day cycle. Cohort 2 will not be enrolled in the US.
Receives: Drug: Cusatuzumab; Drug: Venetoclax
Cohort 3: Cusatuzumab + Venetoclax + Azacitidine (CVA)ExperimentalParticipants enrolled at US sites will receive cusatuzumab 10 mg/kg and potentially escalate to 20 mg/kg IV in combination with azacitidine 75 mg/m^2 SC or IV plus venetoclax ramp-up to 400 mg orally (as background therapies). Participants enrolled from ex-US sites will receive cusatuzumab 20 mg/kg and potentially de-escalate to 10 mg/kg IV in combination with azacitidine 75 mg/m^2 SC or IV plus venetoclax ramp-up to 400 mg orally (as background therapies).
Receives: Drug: Cusatuzumab; Drug: Azacitidine; Drug: Venetoclax

What is being measured

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

  1. Frequency and Severity of Adverse Events (AEs), Laboratory Abnormalities, and Physical Exam Findings as a Measure of Safety

    Frequency and severity of AEs, laboratory abnormalities, and physical exam findings will be reported.

    Measured: Up to 42 months

Secondary outcomes (12)

  1. Serum Concentration of Cusatuzumab

    Serum concentration of cusatuzumab will be assessed.

    Measured: Up to 23 months

  2. Number of Participants with Anti-cusatuzumab Antibodies

    Number of participants with anti-drug antibodies to cusatuzumab will be reported.

    Measured: Up to 23 months

  3. Percentage of Participants with Complete Response (CR)

    Percentage of participants with complete response based on European Leukemia Network (ELN) 2017 response criteria assessment will be reported.

    Measured: Up to 42 months

  4. Percentage of Participants with Complete Remission with Partial Hematological Recovery (CRh)

    Percentage of participants with CRh will be reported based on ELN 2017 response criteria assessment.

    Measured: Up to 42 months

  5. Percentage of Participants with CR with Incomplete Recovery (CRi)

    Percentage of participants with CRi will be reported based on ELN 2017 response criteria assessment.

    Measured: Up to 42 months

  6. Percentage of Participants with CR plus CRh

    Percentage of participants with CR plus CRh will be reported based on ELN 2017 response criteria assessment.

    Measured: Up to 42 months

  7. Overall Response Rate (ORR)

    ORR is defined as percentage of participants with CR, CRh and CRi based on ELN 2017 response criteria assessment.

    Measured: Up to 42 months

  8. Percentage of Participants with CR without MRD

    Percentage of participants with CR without minimal residual disease (MRD) will be reported and is defined as less than (<) 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level <10^-3).

    Measured: Up to 42 months

  9. Percentage of Participants with Negative MRD who Achieved CR, CRh, CRi, or Morphologic Leukemia-free State (MLFS)

    Percentage of participants with negative MRD who achieved CR, CRh, CRi, or MLFS will be reported and is defined as < 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level <10^-3).

    Measured: Up to 42 months

  10. Cohort 2 and 3: Time to Response

    Time to response is defined as time from first dose to achieving the first response of CR, CRh, or CRi.

    Measured: Up to 42 months

  11. Cohort 2 and 3: Duration of Response

    Duration of response is defined as time from achieving the first response of CR, CRh, or CRi to hematologic relapse or death of any cause.

    Measured: Up to 42 months

  12. Cohort 2 and 3: Red Blood Cell (RBC) or Platelet Transfusion Independence

    Transfusion independence (RBC or platelets) is defined as a period of greater than or equal to (>=) 56 consecutive days with no transfusion between first dose of study drug and the last dose of study drug +30 days.

    Measured: Up to 42 months

Timeline

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

  1. First posted5 Nov 2019
  2. Study start23 Dec 2019
  3. Primary completion15 May 2027 (estimated)
  4. Study completion15 May 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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04150887
Sponsor's protocol ID
ELEV20235
Other IDs
2019-002808-41, ELEV20235, 74494550AML1003, 2019
Acronym
ELEVATE
Status last verified
May 2026
First submitted
1 Nov 2019
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Roboz GJ, Pabst T, Aribi A, Brandwein JM, Dohner H, Fiedler W, Riether C, Gandini D, Geddes M, Hou JZ, Yee K, Hultberg A, Huselton E, Jacobs J, Zabrocki P, Lech-Maranda E, Louwers M, Nottage K, Platzbecker U, Rampal R, Salman M, Shah P, Wilson K, Stuart M, Subklewe M, Sumbul A, Wang ES, Wierzbowska A, Yao B, Patel R, George A, Islam N, Smith C, Boyiadzis M, Borthakur G. Cusatuzumab combined with venetoclax with or without azacitidine in unfit patients with newly diagnosed acute myeloid leukemia: phase Ib ELEVATE study. Haematologica. 2026 Sep 3. doi: 10.3324/haematol.2026.300917. Online ahead of print.

    PubMed 42689432

  • Pabst T, Papayannidis C, Demirkan F, Doronin V, Fogliatto LM, Guttke C, Gyan E, Hamad N, Herrera P, Hultberg A, Jacobs J, Johnson AJ, Langlois A, Ma X, Martinelli G, Arnan M, Muller R, Nottage K, Ofran Y, Ozcan M, Samoilova O, Tolbert JA, Trudel GC, Xiu L, Vey N, Wei AH. Cusatuzumab plus azacitidine in newly diagnosed acute myeloid leukaemia ineligible for intensive chemotherapy (CULMINATE): part one of a randomised, phase 2, dose optimisation study. Lancet Haematol. 2023 Nov;10(11):e902-e912. doi: 10.1016/S2352-3026(23)00207-7.

    PubMed 37914483

  • Dewulf J, Flieswasser T, Delahaye T, Vangestel C, Miranda A, de Haard H, Jacobs J, Smits E, Van den Wyngaert T, Elvas F. Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models. EJNMMI Radiopharm Chem. 2023 Apr 24;8(1):8. doi: 10.1186/s41181-023-00194-3.

    PubMed 37093350

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cusatuzumab, Azacitidine and Venetoclax in people with Leukemia, Myeloid, Acute, run by OncoVerity, Inc. at 23 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 6 inclusion and 5 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 12 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 23 sites in United States, Canada, Germany, Poland, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Frequency and Severity of Adverse Events (AEs), Laboratory Abnormalities, and Physical Exam Findings as a Measure of Safety (time frame: Up to 42 months). 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 NCT04150887, which also lists 3 linked publications.

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 12 May 2026.

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