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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR-TRC-14004196 | Registry Identifier | Chinese Clinical Trial Registry (ChiCTR) |
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| Name | Class |
|---|---|
| European Society for Blood and Marrow Transplantation | NETWORK |
A multicentre, prospective, open-label clinical study, including a randomized controlled study in low or intermediate-risk group patients, and a cohort study of maintenance treatment with decitabine after ASCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| auto | Active Comparator | patients receive autologous SCT |
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| haplo | Active Comparator | patients receive haplo-SCT |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSCT | Procedure | Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved. |
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| Measure | Description | Time Frame |
|---|---|---|
| Leukemia-Free Survival | Defined as the survival duration starting at the day of graft infusion, terminating at the day of death, morphological relapse or the end of follow-up. | Five years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined as the survival duration starting at the day of graft infusion, terminating at the day of death or the end of follow-up. | Five years |
| Cumulative relapse incidence | Defined as the cumulative incidence of morphological relapse after the day of graft infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Including incidence and severity of acute and chronic GVHD, activity of daily living, psychological status, recovery of professional activity, social adaption, etc. | Five years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Depei Wu, M.D., Ph.D. | Contact | +86 512 67781856 | wudepei@medmail.com.cn | |
| Jia Chen, M.D. | Contact | +86 512 67781856 | chenjia@suda.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Depei Wu, M.D., Ph.D. | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fisrt Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Five years |
| Non-relapse Mortality | Defined as the cumulative incidence of death without cause of disease recurrence, which include the cause of GVHD, infection, hemorrhage, organic function failure, etc. | Five years |
| Cumulative incidence of engraftment | Defined as the cumulative incidence of durable complete donor chimerism detected by STR-PCR. | 180 days |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |