Trial Title:
IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)
NCT ID:
NCT06647862
Condition:
Chronic Myelomonocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Azacitidine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
IMM01
Description:
IV infusion
Arm group label:
IMM01 in combination with azacitidine
Other name:
Timdarpacept
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
subcutaneous injection
Arm group label:
IMM01 in combination with azacitidine
Arm group label:
placebo in combination with azacitidine
Intervention type:
Drug
Intervention name:
Placebo
Description:
IV infusion
Arm group label:
placebo in combination with azacitidine
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18 years old, regardless of gender;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Life expectancy ≥ 12 weeks;
- Patients with CMML diagnosed according to WHO 2016 criteria, including CMML-1 and
CMML-2;
- White blood cell count ≤ 13×10⁹/L before the first treatment with the study drug
(hydroxyurea and leukapheresis are allowed, but not within 3 days prior to the first
treatment with the study drug).
- Patients must be treatment-naïve to any hypomethylating agents (e.g., azacitidine,
decitabine), chemotherapy or allogeneic stem cell transplant for CMML.
Immunomodulators (thalidomide, lenalidomide), immunosuppressants (antithymocyte
globulin, cyclosporine), targeted agents (ruxolitinib), etc. are also excluded, as
these agents are considered disease-modifying therapies. Note: During screening and
study participation, subjects may continue oral corticosteroids for diseases other
than CMML (e.g. asthma) at a stable daily dose equivalent to ≤ 10 mg prednisone. In
addition, supportive care in the form of blood transfusions or growth factors is not
considered prior therapy in this case and is permitted prior to and as needed during
the study.
Exclusion Criteria:
- Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein;
- History of allogeneic stem cell transplant and other organ transplants; Patients who
have undergone autologous haematopoietic stem cell transplant;
- No prior diagnosis of: therapy-related myelodysplastic syndrome(t-MDS); MDS evolved
from a pre-existing myeloproliferative neoplasm (MPN) ;MDS/MPN including atypical
chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and
unclassifiable MDS/MPN. Patients positive for BCR-ABL fusion genes, PDGFRA, PDGFRB,
and FGF1 rearrangements need to be excluded;
- Current or history of central nervous system (CNS) leukemia, extramedullary
leukemia, or myeloid sarcoma;
- Diagnosis of other malignant neoplasms within 5 years prior to the first dose.
Exceptions: a. Radically treated cervical carcinoma in situ or non-melanoma skin
cancer; b. a second primary cancer that has been curatively treated and has no
recurrence within five years;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhujiang Hospital of Southern Medical University
Address:
City:
Zhujiang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
chaoyang Song
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
xin Du
Facility:
Name:
The Second Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
jinhai Ren
Facility:
Name:
Harbin First Hospital
Address:
City:
Harbin
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
tiejun Gong
Facility:
Name:
First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
lijie Han
Investigator:
Last name:
xinsheng Xie
Email:
Principal Investigator
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
hu Zhou
Facility:
Name:
Henan Provincial People's Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
zunmin Zhu
Facility:
Name:
The First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
haiping Yang
Facility:
Name:
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
weiming Li
Facility:
Name:
Zhongnan Hospital Affiliated to Wuhan University
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
fuling Zhou
Facility:
Name:
Zhongda Hospital affiliated to Southeast University
Address:
City:
Nanjing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
zheng Ge
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
fei Li
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
hai Lin
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shenyang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
wei Yang
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
xiaojing Yan
Facility:
Name:
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College;
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhijian Xiao, PHD
Phone:
022-23909184
Email:
zjxiao@ihcams.ac.cn
Facility:
Name:
The Second Affiliated Hospital of Kunming Medical University
Address:
City:
Kunming
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
zeping Zhou
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
hongyan Tong, PHD
Phone:
0571-87235589
Email:
hongyantong@aliyun.com
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
qian Jiang
Facility:
Name:
Affiliated Cancer Hospital of Chongqing University
Address:
City:
Chongqing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
jieping Li
Facility:
Name:
Shanghai Sixth People's Hospital
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
chunkang Chang
Facility:
Name:
Tianjin People's Hospital
Address:
City:
Tianjin
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
xingli Zhao
Start date:
October 24, 2024
Completion date:
October 24, 2029
Lead sponsor:
Agency:
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Agency class:
Other
Source:
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06647862
