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

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ClinicalTrials.gov Identifier: NCT04150887
Recruitment Status : Active, not recruiting
First Posted : November 5, 2019
Last Update Posted : December 29, 2022
Sponsor:
Collaborator:
argenx
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: Cusatuzumab Drug: Azacitidine Drug: Venetoclax Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Phase 1b Study of JNJ-74494550 (Cusatuzumab; Anti-CD70 Monoclonal Antibody) in Combination With Background Therapy for the Treatment of Subjects With Acute Myeloid Leukemia
Actual Study Start Date : December 23, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Cohort 2: Cusatuzumab + Venetoclax
Participants 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.
 Drug: Cusatuzumab
Cusatuzumab will be administered as a dose of 10mg/kg or 20mg/kg intravenously.
Other Names:
  • JNJ-74494550
  • ARGX-110

Drug: Venetoclax
Venetoclax will be administered orally and the dose will ramp-up to 400 mg.
Other Name: Venclexta
Experimental: Cohort 3: Cusatuzumab + Venetoclax + Azacitidine (CVA)
Participants 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).
 Drug: Cusatuzumab
Cusatuzumab will be administered as a dose of 10mg/kg or 20mg/kg intravenously.
Other Names:
  • JNJ-74494550
  • ARGX-110

Drug: Azacitidine
Azacitidine will be administered 75 mg/m^2 subcutaneously or intravenously.
Other Name: Vidaza

Drug: Venetoclax
Venetoclax will be administered orally and the dose will ramp-up to 400 mg.
Other Name: Venclexta


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04150887


Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
argenx
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04150887    
Other Study ID Numbers: CR108710
2019-002808-41 ( EudraCT Number )
74494550AML1003 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: December 29, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Azacitidine
 Venetoclax
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors