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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
| The Second People's Hospital of Huai'an | OTHER |
| Soochow Hopes Hematology Hospital | UNKNOWN |
| Hygeia Suzhou Yongding Hospital |
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Patients who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic cell transplantation (haplo HCT) are potential candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an coinfusion of an unrelated cord blood unit (haplo-cord HCT) in addition to Arm A. Progression-free survival, overall survival, cumulative incidence of relapse and nonrelapse mortality will be recorded as endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haplo-HCT | Active Comparator | people enrolled in this arm will receive a typical haploidentical donor HCT |
|
| Haplo-cord HCT | Experimental | people enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical donor HCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| haplo-HCT | Procedure | HCT will be performed with a haploidentical donor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | estimated overall survival at 3 year | 3 year after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | estimated progression-free survival at 3 year | 3 year after randomization |
| Cumulative incidence of relapse | estimated cumulative incidence of nonrelapse mortality at 3 year |
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Inclusion Criteria:
Exclusion Criteria:
Acute promyelocytic leukaemia (AML subtype M3)
With other malignances
Failing to acquire a suitable UCB unit
With previous history of autologous haematopoietic cell transplantation (auto-HCT), allogeneic haematopoietic cell transplantation (allo-HCT) or chimaeric antigen receptor T-cell therapy
With uncontrolled infection intolerant to haplo-HCT
With severe organ dysfunction
In pregnancy or lactation period
With any conditions not suitable for the trial (investigators' decision)
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| 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 Second People's Hospital of Huai'an | Huai'an | Jiangsu | 223000 | China | ||
| The First Affiliated Hospital of Soochow University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38705885 | Derived | Zhou B, Chen J, Liu T, Ye Y, Zhang Y, Ding Y, Liu H, Zhu M, Ma X, Li X, Zhao L, Lin Z, Huang H, Xu Y, Wu D. Haploidentical hematopoietic cell transplantation with or without an unrelated cord blood unit for adult acute myeloid leukemia: a multicenter, randomized, open-label, phase 3 trial. Signal Transduct Target Ther. 2024 May 6;9(1):108. doi: 10.1038/s41392-024-01820-5. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 25, 2023 | |
| Reset | Mar 6, 2024 | |
| Release | Jul 15, 2024 | |
| Reset | Oct 11, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 25, 2023 | Mar 6, 2024 | |||
| Jul 15, 2024 |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| UNKNOWN |
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| haplo-cord HCT |
| Procedure |
Haploidentical donor HCT will be performed with coinfusion of unrelated cord blood unit |
|
| 3 year after randomization |
| Cumulative incidence of non-relapse mortality | estimated nonrelapse mortality at 3 year | 3 year after randomization |
| Suzhou |
| Jiangsu |
| 215006 |
| China |
| Soochow Hopes Hematology Hospital | Suzhou | Jiangsu | 215100 | China |
| Hygeia Suzhou Yongding Hospital | Suzhou | Jiangsu | 215200 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Oct 11, 2024 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |