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NCT Number: NCT04150887

Cusatuzumab in Combination With Background Therapy for the Treatment of Participants 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Leukemia, Myeloid, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Cusatuzumab

Drug

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

Other names: JNJ-74494550, ARGX-110

Azacitidine

Drug

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

Other names: Vidaza

Venetoclax

Drug

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

Other names: Venclexta

Primary outcomes

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

    Time frame: Up to 42 months

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

Secondary outcomes

  1. Serum Concentration of Cusatuzumab

    Time frame: Up to 23 months

    Serum concentration of cusatuzumab will be assessed.

  2. Number of Participants with Anti-cusatuzumab Antibodies

    Time frame: Up to 23 months

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

  3. Percentage of Participants with Complete Response (CR)

    Time frame: Up to 42 months

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

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

    Time frame: Up to 42 months

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

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

    Time frame: Up to 42 months

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

  6. Percentage of Participants with CR plus CRh

    Time frame: Up to 42 months

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

  7. Overall Response Rate (ORR)

    Time frame: Up to 42 months

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

  8. Percentage of Participants with CR without MRD

    Time frame: Up to 42 months

    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).

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

    Time frame: Up to 42 months

    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).

  10. Cohort 2 and 3: Time to Response

    Time frame: Up to 42 months

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

  11. Cohort 2 and 3: Duration of Response

    Time frame: Up to 42 months

    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.

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

    Time frame: Up to 42 months

    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.

Sponsors and collaborators

Lead sponsor

OncoVerity, Inc.

Industry

Collaborators

  • Janssen Research & Development, LLC
  • argenx

Registry information

Official study 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

Acronym: ELEVATE

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Nov 5, 2019
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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