IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)
Condition(s) studied
Investigational drug(s) / intervention(s)
IMM01: IV infusion
Azacitidine: subcutaneous injection
Placebo: IV infusion
Study 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.
Eligibility
Primary outcome measure(s)
- Complete remission( CR) rate — approximately 24 months
CR rate: CR rate determined by Independent Review Committee (IRC) based on IWG2006 MDS efficacy evaluation criteria; - Overall survival (OS) — approximately 24 months
Overall survival (OS): Time from randomization to death from any cause;
Trial sites (43)
| Facility | City | Region | Status |
|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | Recruiting |
| China-Japan Friendship Hospita | Beijing | Beijing Municipality | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | Not Yet Recruiting |
| First Hospital of Lanzhou University | Lanzhou | Gansu | Not Yet Recruiting |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Gaungxi | Recruiting |
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | Recruiting |
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | Not Yet Recruiting |
| Zhujiang Hospital of Southern Medical University | Zhujiang | Guangdong | Not Yet Recruiting |
| Guangdong Provincial People's Hospital | Guangzhou | Guangzhou | Recruiting |
| Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | Recruiting |
| Affiliated Hospital of Hebei University | Shijiazhuang | Hebei | Not Yet Recruiting |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | Not Yet Recruiting |
| Harbin First Hospital | Harbin | Heilongjiang | Not Yet Recruiting |
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| Henan Provincial People's Hospital | Zhengzhou | Henan | Not Yet Recruiting |
| The First Affiliated Hospital of Henan University of Science and Technology | Zhengzhou | Henan | Not Yet Recruiting |
| Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| Zhongnan Hospital Affiliated to Wuhan University | Wuhan | Hubei | Not Yet Recruiting |
| Xiangyang Central Hospital | Xiangyang | Hubei | Recruiting |
| Xiangya Hospital Central South University | Changsha | Hunan | Not Yet Recruiting |
| Changzhou First People's Hospital | Changzhou | Jiangsu | Recruiting |
| Jiangsu Province Hospital | Nanjing | Jiangsu | Not Yet Recruiting |
| Zhongda Hospital affiliated to Southeast University | Nanjing | Jiangsu | Recruiting |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | Not Yet Recruiting |
| Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | Recruiting |
| Jiangsu Subei People's Hospital | Yangzhou | Jiangsu | Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | Not Yet Recruiting |
| The First Hospital of Jilin University | Changchun | Jilin | Recruiting |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | Recruiting |
| The First Hospital of China Medical University | Shenyang | Liaoning | Not Yet Recruiting |
| Qilu Hospital of Shandong University | Jinan | Shandong | Recruiting |
| Shaanxi Provincial People's Hospital | Xi’an | Shanxi | Recruiting |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | Not Yet Recruiting |
| Yibin Second People's Hospital | Yibin | Sichuan | Recruiting |
| Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; | Tianjin | Tianjin Municipality | Recruiting |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | Recruiting |
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | Not Yet Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | Recruiting |
| Ningbo First Hospital | Ningbo | Zhejiang | Recruiting |
+ 3 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06647862 on ClinicalTrials.gov ↗ ← All trials in China