A multicenter, open-label, randomized, phase 2 study of venetoclax and azacitidine plus cusatuzumab versus venetoclax and azacitidine alone in newly diagnosed AML patients who are not candidates for intensive therapy

Clinical Trial Details

The purpose of this study is to evaluate the efficacy of adding cusatuzumab to venetoclax plus azacitidine (VAC) compared to venetoclax plus azacitidine (VA) alone for patients with acute myeloid leukemia (AML).

Cusatuzumab is considered investigational which means it has not been approved by the U.S. Food and Drug Administration (FDA). Azacitidine and venetoclax are both FDA-approved.

Cusatuzumab is given by intravenous infusion (IV) at a dose of 20 mg/kg (based on weight). IV infusion means a thin plastic tube called an IV catheter is inserted into the vein. Each infusion will take approximately 4-5 hours

The total length of participation in this research will vary depending on how each participant responds to treatment.

Key Eligibility:

Open to men and women above the age of 18 who have been diagnosed with AML according to ICC 2022.
Participants must not have received a hypomethylating agent (HMA) such as azacitidine or venetoclax for MDS or myeloproliferative neoplasm.

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Gail J Roboz, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2411028140

ClinicalTrials.gov:

NCT06384261

Status

Open to Enrollment

Age Group

Adult

Disease

Leukemia

Acute Myeloid Leukemia