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A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

NCT04023526 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-08-20

Study results available
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Summary

The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy.

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DRUG

Azacitidine

Azacitidine SC or IV will be administered at a standard dose of 75 mg/m\^2 on days 1-7 of each cycle.

DRUG

Cusatuzumab

Cusatuzumab IV will be administered as 10 mg/kg or 20 mg/kg on days 3 and 17 of each cycle.

Sponsors & Collaborators

  • argenx

    collaborator INDUSTRY

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • OncoVerity, Inc.

    lead INDUSTRY

Principal Investigators

  • Clayton Smith, MD · OncoVerity, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-29
Primary Completion
2023-08-15
Completion
2026-05-15
FDA Drug
Yes

Countries

  • Australia
  • Brazil
  • France
  • Israel
  • Italy
  • Russia
  • Spain
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04023526 on ClinicalTrials.gov