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RECRUITING
NCT06647862
PHASE3

IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)

Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

View on ClinicalTrials.gov

Summary

This study is a randomized, controlled, double-blind, multicenter, phase Ⅲ clinical study to evaluate the efficacy of IMM01(timdarpacept) in combination with azacitidine versus placebo in combination with azacitidine in patients with newly diagnosed chronic leukemia monocytic (CMML1-2).Primary endpoint are Complete remission rate and Overall survival.

Official title: A Randomized, Controlled, Double-Blind, Multicenter, Phase Ⅲ Study to Evaluate the Efficacy and Safety of IMM01 (Timdarpacept) in Combination With Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2024-11-11

Completion Date

2029-10-24

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

DRUG

IMM01

IV infusion

DRUG

Azacitidine

subcutaneous injection

DRUG

Placebo

IV infusion

Locations (43)

Anhui Provincial Hospital

Hefei, Anhui, China

China-Japan Friendship Hospita

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

First Hospital of Lanzhou University

Lanzhou, Gansu, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Gaungxi, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Zhujiang Hospital of Southern Medical University

Zhujiang, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangzhou, China

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Affiliated Hospital of Hebei University

Shijiazhuang, Hebei, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin First Hospital

Harbin, Heilongjiang, China

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Zhengzhou, Henan, China

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Zhongnan Hospital Affiliated to Wuhan University

Wuhan, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Changzhou First People's Hospital

Changzhou, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Zhongda Hospital affiliated to Southeast University

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Jiangsu Subei People's Hospital

Yangzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shaanxi Provincial People's Hospital

Xi’an, Shanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Yibin Second People's Hospital

Yibin, Sichuan, China

Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College;

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Ningbo First Hospital

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Peking University People's Hospital

Beijing, China

Tianjin People's Hospital

Tianjin, China