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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04150887
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
argenx BVBA
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE November 1, 2019
First Posted Date  ICMJE November 5, 2019
Last Update Posted Date January 31, 2020
Actual Study Start Date  ICMJE December 23, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2019)
Frequency and Severity of Adverse Events (AEs), Laboratory Abnormalities, and Physical Exam Findings as a Measure of Safety [ Time Frame: Up to 32 months ]
Frequency and severity of AEs, laboratory abnormalities, and physical exam findings will be reported.
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2019)
Frequency and Severity of Adverse Events (AEs), Laboratory Abnormalities, and Physical Exam Findings as a Measure of Safety [ Time Frame: Up to 2.3 years ]
Frequency and severity of AEs, laboratory abnormalities, and physical exam findings will be reported.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2019)
  • Serum Concentration of Cusatuzumab [ Time Frame: Up to 32 months ]
    Serum concentration of cusatuzumab will be assessed.
  • Number of Participants with Anti-cusatuzumab Antibodies [ Time Frame: Up to 32 months ]
    Number of participants with anti-drug antibodies to cusatuzumab will be reported.
  • Percentage of Participants with Complete Response (CR) [ Time Frame: Up to 32 months ]
    Percentage of participants with complete response based on European Leukemia Network (ELN) 2017 response criteria assessment will be reported.
  • Percentage of Participants with Complete Remission with Partial Hematological Recovery (CRh) [ Time Frame: Up to 32 months ]
    Percentage of participants with CRh will be reported based on ELN 2017 response criteria assessment.
  • Percentage of Participants with CR plus CRh [ Time Frame: Up to 32 months ]
    Percentage of participants with CR plus CRh will be reported based on ELN 2017 response criteria assessment.
  • Percentage of Participants with CR with Incomplete Recovery (CRi) [ Time Frame: Up to 32 months ]
    Percentage of participants with CRi will be reported based on ELN 2017 response criteria assessment.
  • Overall Response Rate (ORR) [ Time Frame: Up to 32 months ]
    ORR is defined as percentage of participants with CR, CRh and CRi based on ELN 2017 response criteria assessment.
  • Percentage of Participants with CR without MRD [ Time Frame: Up to 32 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).
  • Percentage of Participants with Negative MRD who Achieved CR, CRh, CRi, or Morphologic Leukemia-free State (MLFS) [ Time Frame: Up to 32 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).
  • Time to Response [ Time Frame: Up to 32 months ]
    Time to response is defined as time from first dose to achieving the first response of CR, CRh, or CRi.
  • Duration of Response [ Time Frame: Up to 32 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.
  • Red Blood Cell (RBC) or Platelet Transfusion Independence [ Time Frame: Up to 32 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2019)
  • Serum Concentration of Cusatuzumab [ Time Frame: Up to 2.3 years ]
    Serum concentration of cusatuzumab will be assessed.
  • Number of Participants with Anti-cusatuzumab Antibodies [ Time Frame: Up to 2.3 years ]
    Number of participants with anti-drug antibodies to cusatuzumab will be reported.
  • Percentage of Participants with Complete Response (CR) [ Time Frame: Up to 2.3 years ]
    Percentage of participants with complete response based on European Leukemia Network (ELN) 2017 response criteria assessment will be reported.
  • Percentage of Participants with Complete Remission with Partial Hematological Recovery (CRh) [ Time Frame: Up to 2.3 years ]
    Percentage of participants with CRh will be reported based on ELN 2017 response criteria assessment.
  • Percentage of Participants with CR plus CRh [ Time Frame: Up to 2.3 years ]
    Percentage of participants with CR plus CRh will be reported based on ELN 2017 response criteria assessment.
  • Percentage of Participants with CR with Incomplete Recovery (CRi) [ Time Frame: Up to 2.3 years ]
    Percentage of participants with CRi will be reported based on ELN 2017 response criteria assessment.
  • Overall Response Rate (ORR) [ Time Frame: Up to 2.3 years ]
    ORR is defined as percentage of participants with CR, CRh and CRi based on ELN 2017 response criteria assessment.
  • Percentage of Participants with CR without MRD [ Time Frame: Up to 2.3 years ]
    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).
  • Percentage of Participants with Negative MRD who Achieved CR, CRh, CRi, or Morphologic Leukemia-free State (MLFS) [ Time Frame: Up to 2.3 years ]
    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).
  • Time to Response [ Time Frame: Up to 2.3 years ]
    Time to response is defined as time from first dose to achieving the first response of CR, CRh, or CRi.
  • Duration of Response [ Time Frame: Up to 2.3 years ]
    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.
  • Red Blood Cell (RBC) or Platelet Transfusion Independence [ Time Frame: Up to 2.3 years ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia, Myeloid, Acute
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cohort 1: Cusatuzumab + Azacitidine (CA)
    Participants will receive cusatuzumab 20 milligram per kilogram (mg/kg) intravenously (IV) in combination with azacitidine 75 milligram per meter square (mg/m^2) subcutaneously (SC) or IV (as background therapy).
    Interventions:
    • Drug: Cusatuzumab
    • Drug: Azacitidine
  • Experimental: Experimental: Cohort 2: Cusatuzumab + Venetoclax (CV)
    Participants enrolled in this cohort (applicable only for US sites) will receive cusatuzumab 20 mg/kg IV in combination with venetoclax ramp-up to 400 mg orally (as background therapy).
    Interventions:
    • Drug: Cusatuzumab
    • Drug: Venetoclax
  • 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).
    Interventions:
    • Drug: Cusatuzumab
    • Drug: Azacitidine
    • Drug: Venetoclax
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2022
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of acute myeloid leukemia (AML) according to World Health Organization 2016 criteria . Participants with acute promyelocytic leukemia (APL) with t (15;17) or its molecular equivalent (promyelocytic leukemia/retinoic acid receptor alpha [PML RAR alpha]) 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE Canada,   Germany,   Poland,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04150887
Other Study ID Numbers  ICMJE CR108710
2019-002808-41 ( EudraCT Number )
74494550AML1003 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE argenx BVBA
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP