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

OncoVerity

Status and phase: Active, not recruiting; Phase 1

Conditions: Leukemia, Myeloid, Acute

Treatments: Drug: Azacitidine; Drug: Venetoclax; Drug: Cusatuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04150887

ELEV20235 (Other Identifier)

2019-002808-41 (EudraCT Number)

74494550AML1003 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

61 participants in 2 patient groups

Experimental: Cohort 2: Cusatuzumab + Venetoclax

Experimental group

Description:

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.

Treatment:

Drug: Venetoclax

Drug: Cusatuzumab

Cohort 3: Cusatuzumab + Venetoclax + Azacitidine (CVA)

Experimental group

Description:

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).

Treatment:

Drug: Venetoclax

Drug: Cusatuzumab

Drug: Azacitidine