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
Not provided
Not provided
This is a single-center prospective, non-randomized controlled clinical study in China using CliniMACS TCRα/β+ cell depleted stem cell haploidentical donors versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplantation in children.
1:1 non-randomized controlled clinical study in single center using CliniMACS TCRα/β+ cell depleted stem cell versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplant. The purpose of this study is to obtain 30% decrease grade II-IV aGVHD and better qulity of life for TCRα/β+ cell depleted haploidentical stem cell transplantaion.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Haplo identicle HCT | No Intervention | Beijing haploidenticla HCT is the routinely traditional way used for haploidentical HCT | |
| TCRαβ Depleted haploidentical HCT | Experimental | TCRαβ Depleted haploidentical HCT is experimental used to decrease GVHD and obtain better qulity of life for children with haploidentical HCT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCRαβ Depleted haploidentical HCT | Procedure | Use the CliniMACS TCRα/β deplete from the mobilized peripheral blood stem cells of haploidentical donor in children |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade II-IV acute GVHD | Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation. | day+100 |
| incidence of treatment related mortality(TRM) | compare the incidence of TRM until Day 100 post-transplantation | day +100 |
| Measure | Description | Time Frame |
|---|---|---|
| post HSCT day 1y and 2y GRFS and OS | compare the incidence of GRFS and OS post HSCT 1y and 2y | day +1y and +2y |
| cGVHD post day 1y and 2y | compare the incidence of cGVHD post HSCT 1y and 2y |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Chen, PhD | Contact | 38626161 | 82073 | chenjing@scmc.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jing Chen, PhD | Shanghai Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University | Recruiting | Shanghai | Shanghai Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
TCRαβ depleted HSCT compare to traditional Beijing haploidentical HSCT
Not provided
Not provided
Not provided
Not provided
| day +1y and +2y |
| TRM post day +1y and +2y | compre the incidence of TRM post HSCT day 1y and 2y | day +1y and +2y |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
Not provided
Not provided