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| Name | Class |
|---|---|
| Children's Hospital of Soochow University | OTHER |
| Ruijin Hospital | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Fujian Medical University Union Hospital |
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The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are:
Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL.
Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haplo-cord HCT | Experimental | Patients enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical hematopoietic cell transplantation |
|
| Haplo-HCT | Active Comparator | Patients enrolled in this arm will receive a typical haploidentical hematopoietic cell transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haplo-cord HCT | Biological | Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | estimated progression-free survival at 2 year | 2 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | estimated overall survival at 2 year | 2 years after randomization |
| Cumulative incidence of relapse | estimated cumulative incidence of relapse at 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang XU | Contact | 86+051267781850 | xuyang1020@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang XU | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Zhejiang University | OTHER |
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| Haplo-HCT | Biological | Hematopoietic cell transplantation will be performed with a haploidentical donor |
|
| 2 years after randomization |
| Non-relapse mortality | estimated non-relapse mortality at 2 year | 2 years after randomization |
| Adverse events | Number of participants with adverse events. Frequencies of toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) will be tabulated. | 2 years after randomization |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |