RecruitingPhase 3NCT06647862

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

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)

Sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Enrollment

170 participants

Start Date

Nov 11, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Myelomonocytic Leukemia

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called IMM01 combined with azacitidine (a standard chemotherapy) for people newly diagnosed with chronic myelomonocytic leukemia (CMML) — a rare blood cancer. Researchers want to see if adding IMM01 improves outcomes compared to azacitidine alone. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with CMML (types 1 or 2) - Your white blood cell count is not too high (≤13×10⁹/L) - You have not yet received any systemic treatment for CMML - You are in reasonably good physical condition (ECOG 0–1) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have already received treatment for CMML (except up to 1 cycle of chemotherapy with a washout period) - You have had a bone marrow transplant for CMML Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIMM01

IV infusion

DRUGAzacitidine

subcutaneous injection

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT06647862

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