A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)
- Conditions
- Myelodysplastic Syndromes(MDS)
- Interventions
- Drug: Lemzoparlimab+Azacitidine (AZA)
- Registration Number
- NCT05709093
- Lead Sponsor
- TJ Biopharma Co., Ltd.
- Brief Summary
This phase3 study is a randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of Lemzoparlimab for injection in combination with AZA versus AZA monotherapy as first-line therapy in treatment-naïve subjects with intermediate- and high-risk MDS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- Male or female, ≥ 18 years of age at the time of signing the ICF.
- Subjects with intermediate- and high-risk MDS who are confirmed by bone marrow aspiration or pathological biopsy according to the diagnostic criteria of World Health Organization (WHO) 2016 or who are eligible for blasts in bone marrow and peripheral blood < 20% and have a score > 3.5 according to the revised International Prognostic Scoring System (IPSS-R).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
- Subjects without any prior anti-tumor therapy for MDS, including demethylated drugs (eg, AZA, decitabine), chemotherapy, targeted therapy, or HSCT. The blood transfusion or use of hematopoietic growth factors and supplementation of hematopoietic raw materials such as folic acid, vitamin B12 are permitted. For patients who ever took lenalidomide, thalidomide, antithymocyte globulin (ATG), or ciclosporin before study entry, there should be a washout period of at least 28 days prior to the first dose.
- Subjects who are eligible for HSCT and have no pre-scheduled HSCT at screening, or subjects who are ineligible for HSCT and have no scheduled HSCT at screening
- Expected survival ≥ 12 weeks
- Subjects with adequate organ function and laboratory tests meet the following requirements
- Female subjects of childbearing potential or male subjects whose partner is a woman of childbearing potential are required to use effective contraception throughout the treatment period and until 6 months after the treatment period.
- Subjects must be willing to provide available diagnostic evidence or undergo bone marrow aspiration and biopsy before study treatment, and must be willing to undergo bone marrow aspiration and biopsy after receiving study treatment.
- Subjects must give informed consent before starting the study and sign written ICF voluntarily by themselves (or their legal representatives). Subjects or their legal representatives should be able to communicate well with investigators and agree to adhere with the study protocol and complete the study
- Patients who have transformed from MDS to AML, or have been diagnosed with treatment-related MDS (t-MDS), or patients with myeloproliferative neoplasia (MPN) or myelodysplastic syndrome/myeloproliferative disorder (MDS/MPN) that meet WHO 2016 criteria
- Previously received any anti-CD47 antibody or SIRPα antibody or the drugs targeting the same target
- Subjects have received or plan to receive the allogeneic stem cell transplantation or organ transplantation during the study
- History of chronic hemolytic anemia due to other diseases or clinically significant positive hemolysis-related test at screening (except positive hemolysis test due to MDS)
- Concurrent participation in another interventional clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Subjects plan to receive other anti-tumor therapies, including but not limited to chemotherapy, biotherapy and immunotherapy, while participating in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AZA monotherapy Azacitidine (AZA) - Lemzoparlimab in combination with AZA Lemzoparlimab+Azacitidine (AZA) -
- Primary Outcome Measures
Name Time Method Overall Survival Overall Survival(OS) From date of randomization until the date of first documented progression or date from any cause,whichever came first, assessed up to 50 months.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Bei Jing, China
Beijing Gaobo Boren Hospital Co., Ltd
🇨🇳Beijing, Bei Jing, China
The First Affiliated Hospital Of Bengbu Medical College
🇨🇳Bengbu, An Hui, China
THE First Affiliated Hospital Of Anhui Medical University
🇨🇳Hefei, An Hui, China
The First Affilated Hospital Of USTC Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Peking University Third Hospital
🇨🇳Beijing, Bei Jing, China
The First Affiliated Hospital of PLA Army Military Medical University
🇨🇳Chongqing, Chong Qing, China
The Second Affiliated Hospital of Army Medical University
🇨🇳Chongqing, Chong Qing, China
The Affiliated Zhongshan Hospital of Xiamen University
🇨🇳Xiamen, Fu Jian, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guang Dong, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, He Nan, China
Harbin First Hospital
🇨🇳Harbin, Hei Long Jiang, China
Tongji Medical College of HUST
🇨🇳Wuhan, Hu Bei, China
Changsha Third Hospital
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chong Qing, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guang Dong, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guang Dong, China
Southern Hospital of Southern Medical University
🇨🇳Guangzhou, Guang Dong, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guang Dong, China
First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, He Nan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, He Nan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, He Nan, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The first hospital of Jilin University
🇨🇳Chang chun, Ji Lin, China
Affiliated Hospital of North Sichuan Medical College
🇨🇳Nanchong, Si Chuan, China
The Affiliated Hosptial Of XuZhou Medical University
🇨🇳Xuzhou, Jiang Su, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiang XI, China
The First Affiliated Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shaanxi Provincial People's Hospital
🇨🇳Xian, Shaan XI, China
The Second Affiliated Hospital of Xi'an Jiaotong University Medical College
🇨🇳Xi'an, Shaanxi, China
Cheeloo College of Medicine, Shandong University
🇨🇳Jinan, Shan Dong, China
The Affiliated Hospital of Medical College Qingdao University
🇨🇳Qingdao, Shan Dong, China
The Second Affiliated Hospital of Shandong First Medical University
🇨🇳Tai'an, Shan Dong, China
Taian City Central Hospital
🇨🇳Taian, Shan Dong, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shan XI, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shang Hai, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, Shang Hai, China
Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
🇨🇳Shanghai, Shang Hai, China
Shanghai Sixth People's Hospital
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Si Chuan, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tian Jin, China
Hematology Hospital of Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Zhejiang University Medical College
🇨🇳Hangzhou, Zhe Jiang, China
The First Affiliated Hospital Of WenZhou Medical College
🇨🇳Wenzhou, Zhejiang, China