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

Leukemia, Myeloid, Acute Clinical Trial

— ELEVATE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04150887
• Other study ID #: ELEV20235
• Secondary ID: 2019-002808-41EL
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 23, 2019
• Est. completion date: May 15, 2024

Study information

• Verified date: August 2023
• Source: OncoVerity, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Cusatuzumab
Cusatuzumab will be administered as a dose of 10mg/kg or 20mg/kg intravenously.
• Azacitidine
Azacitidine will be administered 75 mg/m^2 subcutaneously or intravenously.
• Venetoclax
Venetoclax will be administered orally and the dose will ramp-up to 400 mg.

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	McGill University Health Centre	Montreal	Quebec
Canada	University of Toronto	Toronto	Ontario
Germany	Universitaetsklinik Hamburg-Eppendorf	Hamburg
Germany	Universitaetsklinikum Leipzig	Leipzig
Germany	Klinikum der Universitaet Muenchen	München
Poland	Szpital Uniwersytecki w Krakowie	Krakow
Poland	Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi	Lodz
Poland	Instytut Hematologii i Transfuzjologii	Warszawa
Switzerland	INSELSPITAL, Universitätsspital Bern	Bern
Switzerland	Kantonsspital St.Gallen	St. Gallen
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University of Vermont	Burlington	Vermont
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Wisconsin Medical Center	Milwaukee	Wisconsin
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania
United States	University of Rochester	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
OncoVerity, Inc.	argenx, Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 42 months
Secondary	Serum Concentration of Cusatuzumab	Serum concentration of cusatuzumab will be assessed.	Up to 23 months
Secondary	Number of Participants with Anti-cusatuzumab Antibodies	Number of participants with anti-drug antibodies to cusatuzumab will be reported.	Up to 23 months
Secondary	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.	Up to 42 months
Secondary	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.	Up to 42 months
Secondary	Percentage of Participants with CR with Incomplete Recovery (CRi)	Percentage of participants with CRi will be reported based on ELN 2017 response criteria assessment.	Up to 42 months
Secondary	Percentage of Participants with CR plus CRh	Percentage of participants with CR plus CRh will be reported based on ELN 2017 response criteria assessment.	Up to 42 months
Secondary	Overall Response Rate (ORR)	ORR is defined as percentage of participants with CR, CRh and CRi based on ELN 2017 response criteria assessment.	Up to 42 months
Secondary	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).	Up to 42 months
Secondary	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).	Up to 42 months
Secondary	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.	Up to 42 months
Secondary	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.	Up to 42 months
Secondary	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.	Up to 42 months