Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to evaluate whether immediate allogeneic hematopoietic stem cell transplantation (HSCT) is non-inferior to HSCT following bridging therapy in patients with higher-risk myelodysplastic syndrome (HR-MDS).
A total of 236 patients will be randomized in a 1:1 ratio into the immediate transplantation group (n=118) and the disease control group (n=118). The study will continue until at least 124 events occur.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate HSCT Group | Experimental |
| |
| Bridging Therapy Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate HSCT Group | Other | Patients undergo direct allogeneic HSCT. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year Disease-Free Survival (DFS) post-HSCT | Defined as the time from transplantation to two years post-HSCT, with primary events including death or failure to achieve CR or CR equivalent at the time of assessment | 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Allogeneic HSCT | The proportion of patients who undergo HSCT at 4, 8, 16, and 24 weeks post-randomization. | The proportion of patients who undergo HSCT at 4, 8, 16, and 24 weeks post-randomization. |
| Complete Remission (CR) or CR Equivalent Rate from Randomization |
Not provided
Inclusion Criteria:
Age ≥18 years
High relapse risk MDS, defined by:
Eligible for allogeneic HSCT (including matched or mismatched related/unrelated donor transplantations).
Karnofsky Performance Status (KPS) ≥60.
Signed informed consent.
Exclusion Criteria:
Severe organ dysfunction:
History of prior allogeneic HSCT.
Any condition deemed unsuitable by the investigator.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Erlie, doctor | Contact | +86-15122538106 | jiangerlie@ihcams.ac.cn | |
| Xiao Zhijian, doctor | Contact | +86-13821085716 | xiaozhijian@ihcams.ac.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijin | Beijing Municipality | 100044 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bridging Therapy Group |
| Other |
Patients receive one to two cycles of bridging therapy before undergoing allogeneic HSCT. o Bridging Therapy Regimen: Hypomethylating agents (HMA) alone or HMA-based combination chemotherapy, e.g., azacitidine (AZA) 100 mg/day + venetoclax (VEN) 400 mg/day for 7 days. Targeted therapies (e.g., IDH1 inhibitors) will be used for eligible patients. |
|
The percentage of patients achieving CR or CR equivalent, defined as the first documented occurrence. |
| 2-year |
| 2-year Overall Survival (OS) post-HSCT | Defined as the time from HSCT to death from any cause within two years. | 2-year |
| 2-year Leukemia-Free Survival (LFS) from Randomization | The time from randomization to the occurrence of disease progression, relapse, or death from any cause within two years. | 2-year |
| 2-year Quality of Life (QoL) Assessment: 2-year Quality of Life (QoL) Assessment from Randomization | Defined as the assessment of patient-reported QoL starting from randomization over a 2-year period, evaluated using the EORTC QLQ-C30 questionnaire. | 2-year |
| Molecular Clearance Rate | Molecular clearance was defined by two consecutive blood samples obtained at least 4 weeks apart after that were negative for driver mutations in a patient who had been positive before transplantation. | 2-year |
| Zhengzhou University First Affiliated Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
|
| The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army | Recruiting | Jinan | Shandong | China |
|
| People's Liberation Army The General Hospital of Western Theater Command | Recruiting | Chengdu | Sichuan | 610083 | China |
|
| The Second Hospital of Hebei Medical University | Recruiting | Shijia Zhuang | China |
|
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided