Clinical trial NCT05709093: 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)
Official title: A Randomized, Controlled, Open-label, Multicenter 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Myelodysplastic Syndromes(MDS)
Lead sponsor: TJ Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall Survival Overall Survival(OS)
timeFrame: 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 outcomes:
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital Of Bengbu Medical College
state: An Hui
city: Hefei
country: China
facility: THE First Affiliated Hospital Of Anhui Medical University
state: An Hui
city: Hefei
country: China
facility: The First Affilated Hospital Of USTC Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Bei Jing
city: Beijing
country: China
facility: Beijing Gaobo Boren Hospital Co., Ltd
state: Bei Jing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Bei Jing
city: Chongqing
country: China
facility: The First Affiliated Hospital of PLA Army Military Medical University
state: Chong Qing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Army Medical University
state: Chong Qing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chong Qing
city: Xiamen
country: China
facility: The Affiliated Zhongshan Hospital of Xiamen University
state: Fu Jian
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guang Dong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guang Dong
city: Guangzhou
country: China
facility: Southern Hospital of Southern Medical University
state: Guang Dong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guang Dong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guang Dong
city: Luoyang
country: China
facility: First Affiliated Hospital of Henan University of Science and Technology
state: He Nan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: He Nan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: He Nan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: He Nan
city: Harbin
country: China
facility: Harbin First Hospital
state: Hei Long Jiang
city: Wuhan
country: China
facility: Tongji Medical College of HUST
state: Hu Bei
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Changsha Third Hospital
state: Hunan
city: Chang chun
country: China
facility: The first hospital of Jilin University
state: Ji Lin
city: Xuzhou
country: China
facility: The Affiliated Hosptial Of XuZhou Medical University
state: Jiang Su
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiang XI
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Xian
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaan XI
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University Medical College
state: Shaanxi
city: Jinan
country: China
facility: Cheeloo College of Medicine, Shandong University
state: Shan Dong
city: Qingdao
country: China
facility: The Affiliated Hospital of Medical College Qingdao University
state: Shan Dong
city: Tai'an
country: China
facility: The Second Affiliated Hospital of Shandong First Medical University
state: Shan Dong
city: Taian
country: China
facility: Taian City Central Hospital
state: Shan Dong
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shan XI
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shang Hai
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shang Hai
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
state: Shang Hai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Si Chuan
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
state: Si Chuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tian Jin
city: Tianjin
country: China
facility: Hematology Hospital of Chinese Academy of Medical Sciences
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University Medical College
state: Zhe Jiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital Of WenZhou Medical College
state: Zhejiang
Study officials:
References: