Actively Recruiting
IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)
Led by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Updated on 2025-11-25
170
Participants Needed
43
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Life expectancy of at least 12 weeks
- Diagnosis of CMML-1 or CMML-2 according to WHO 2016 criteria
- White blood cell count of 13 x 10^9/L or less before first treatment (hydroxyurea and leukapheresis allowed)
- No prior systemic treatment for CMML (such as azacitidine, decitabine, chemotherapy less than 1 cycle with washout over 28 days, or allogeneic stem cell transplant)
- Stable daily dose of oral corticosteroids equivalent to 10 mg prednisone or less allowed for other diseases
- Supportive care including blood transfusions or growth factors allowed prior to and during the study
You will not qualify if you...
- Previous treatment with anti-CD47 monoclonal antibody or SIRPα fusion protein
- History of allogeneic stem cell transplant, other organ transplants, or autologous hematopoietic stem cell transplant
- Prior diagnosis of therapy-related MDS/MPN, MDS evolved from MDS/MPN, atypical chronic myeloid leukemia, juvenile myelomonocytic leukemia, or unclassifiable MDS/MPN
- Presence of BCR-ABL fusion genes, PDGFRA, PDGFRB, or FGFR1 rearrangements
- Current or past central nervous system leukemia, extramedullary leukemia (except enlarged spleen, liver, or lymph nodes), or myeloid sarcoma
- Diagnosis of other malignant cancers within 3 years before first dose except treated cervical carcinoma in situ, non-melanoma skin cancer, surgery-cured prostate cancer, papillary thyroid cancer, or other second primary cancer treated with no recurrence within 3 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 43 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China
Actively Recruiting
2
China-Japan Friendship Hospita
Beijing, Beijing Municipality, China
Actively Recruiting
3
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
4
First Hospital of Lanzhou University
Lanzhou, Gansu, China
Not Yet Recruiting
5
The First Affiliated Hospital of Guangxi Medical University
Nanning, Gaungxi, China
Actively Recruiting
6
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
7
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Not Yet Recruiting
8
Zhujiang Hospital of Southern Medical University
Zhujiang, Guangdong, China
Not Yet Recruiting
9
Guangdong Provincial People's Hospital
Guangzhou, Guangzhou, China
Actively Recruiting
10
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Actively Recruiting
11
Affiliated Hospital of Hebei University
Shijiazhuang, Hebei, China
Not Yet Recruiting
12
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Not Yet Recruiting
13
Harbin First Hospital
Harbin, Heilongjiang, China
Not Yet Recruiting
14
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
15
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
16
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
17
The First Affiliated Hospital of Henan University of Science and Technology
Zhengzhou, Henan, China
Not Yet Recruiting
18
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
19
Zhongnan Hospital Affiliated to Wuhan University
Wuhan, Hubei, China
Not Yet Recruiting
20
Xiangyang Central Hospital
Xiangyang, Hubei, China
Actively Recruiting
21
Xiangya Hospital Central South University
Changsha, Hunan, China
Not Yet Recruiting
22
Changzhou First People's Hospital
Changzhou, Jiangsu, China
Actively Recruiting
23
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
24
Zhongda Hospital affiliated to Southeast University
Nanjing, Jiangsu, China
Actively Recruiting
25
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Not Yet Recruiting
26
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
27
Jiangsu Subei People's Hospital
Yangzhou, Jiangsu, China
Actively Recruiting
28
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
29
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
30
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
31
The First Hospital of China Medical University
Shenyang, Liaoning, China
Not Yet Recruiting
32
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
33
Shaanxi Provincial People's Hospital
Xi’an, Shanxi, China
Actively Recruiting
34
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
35
Yibin Second People's Hospital
Yibin, Sichuan, China
Actively Recruiting
36
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College;
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
37
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Actively Recruiting
38
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Not Yet Recruiting
39
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
40
Ningbo First Hospital
Ningbo, Zhejiang, China
Actively Recruiting
41
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Not Yet Recruiting
42
Peking University People's Hospital
Beijing, China
Not Yet Recruiting
43
Tianjin People's Hospital
Tianjin, China
Actively Recruiting
Research Team
Y
Yujuan Ma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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