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RECRUITING
NCT06196203
PHASE2

A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes

Sponsor: Akeso

View on ClinicalTrials.gov

Summary

This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination With Azacitidine in Patients With Newly Diagnosed Higher-risk Myelodysplastic Syndromes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-02-07

Completion Date

2026-06

Last Updated

2025-02-11

Healthy Volunteers

No

Interventions

DRUG

AK117

AK117 IV injection

DRUG

Placebo

Placebo IV injection

DRUG

Azacitidine

Azacitidine SC injection

Locations (15)

UCLA Ronald Reagan Medical Center

Los Angeles, California, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States

American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)

Bethesda, Maryland, United States

Maryland Oncology-Columbia

Columbia, Maryland, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Gabrail Cancer Center

Canton, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Oncology Associates of Oregon

Eugene, Oregon, United States

MUSC Hollings Cancer Center

Charleston, South Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Institute of hematolongy&blood diseases hospital, chinese academy of medical sciences&peking union medical college

Tianjin, China