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To determine if the novel regimen of PT/FLU+CY promotes cord blood engraftment in children's leukemia HSCT cohort
PTCy is a well-established haploidentical transplant regimen strategy. Moreover, unrelated cord blood (UCB) plays a critical role in the effects of GVL. However, the engraftment of grafts is unpredictable in the setting of a haplo-cord subsequent transplant. Therefore, applying a novel post-transplant regimen of PT/CY+FLU may selectively promote UCB engraftment in the setting of haplo-cord transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PT/FLU+CY | Experimental | The group consisted of fludarabine (40mg/m2, day-5 to day-3 and day+3, day+4), busulfan (100mg/m2, day-6 to day-3), haplo-PBSC (day0), cyclophosphamide (50mg/kg, day+3, day+4) , and UCB (day+6) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| applying of FLU+CY post-HSCT | Procedure | The conditioning regimen (PT-Cy/Flu group) consisted of fludarabine (40mg/m2, d-5 to d-3 and d+3, d+4), busulfan (100mg/m2, d-6 to d-3), haplo-PBSC (d0), PTCy (50mg/kg, d+3, d+4) and UCB (d+6). |
| Measure | Description | Time Frame |
|---|---|---|
| rate of UCB engraftment | evaluate the regimen if it promotes UCB engraftment | initiate STR detection from day+15 thereafter weekly up to 1 year post-HSCT |
| rate of leukemia free survival | determine the leukemia status post-HSCT | 3 years post-HSCT |
| rate of overall survival | determine the overall survival status post-HSCT | 3 years post-HSCT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongsheng Ruan, MD | Contact | 02062787966 | vimmer@smu.edu.cn | |
| Xiaoqin Feng, MD | Contact | +861382222 | fxq126126@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoqin Feng, MD | Department of Pediatrics, Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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