Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia
NCT ID: NCT04150887
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
61 participants
INTERVENTIONAL
2019-12-23
2026-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Cusatuzumab
Cusatuzumab will be administered as a dose of 10mg/kg or 20mg/kg intravenously.
Venetoclax
Venetoclax will be administered orally and the dose will ramp-up to 400 mg.
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).
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Janssen Research & Development, LLC
INDUSTRY
OncoVerity, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clayton Smith, MD
Role: STUDY_DIRECTOR
OncoVerity, Inc.
Locations
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City of Hope
Duarte, California, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Weill Cornell Medicine
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Vermont
Burlington, Vermont, United States
Wisconsin Medical Center
Milwaukee, Wisconsin, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
University of Toronto
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Universitaetsklinik Hamburg-Eppendorf
Hamburg, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Klinikum der Universitaet Muenchen
München, , Germany
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, , Poland
Instytut Hematologii i Transfuzjologii
Warsaw, , Poland
INSELSPITAL, Universitätsspital Bern
Bern, , Switzerland
Kantonsspital St.Gallen
Sankt Gallen, , Switzerland
Countries
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References
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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.
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.
Other Identifiers
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2019-002808-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ELEV20235
Identifier Type: OTHER
Identifier Source: secondary_id
74494550AML1003
Identifier Type: OTHER
Identifier Source: secondary_id
ELEV20235
Identifier Type: -
Identifier Source: org_study_id
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