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| Name | Class |
|---|---|
| The First Affiliated Hospital of Soochow University | OTHER |
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Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
γδT cells belong to the innate immune system and have a powerful anti-tumor effect. Leukemia patients transplanted with allogeneic hematopoietic stem cells have an important role in controlling leukemia recurrence. Although adoptive immunotherapy using in vitro expanded γδT cells has achieved significant results in patients with solid tumors, infusion of donor γδT cells in leukemia patients undergoing allogeneic hematopoietic stem cell transplantation to prevent leukemia recurrence has not been reported. . This clinical study intends to initially observe the safety and effectiveness of donor γδT cell infusion to prevent recurrence/refractory leukemia salvage allogeneic hematopoietic stem cell transplantation to further improve the transplantation effect of these patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| γδT | Experimental | γδT,Infusion,iv,0.5×10^6-8×10^7γδT /kg,once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| γδT Cell infusion agent | Drug | γδT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of the dose limiting toxicity (DLT) | Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 5 and the number of patients experiencing DLT will be evaluated. | 4 weeks after γδT infusion |
| The incidence of serious adverse events (SAEs) | The incidence of serious adverse events (SAEs) after γδT infusion | 4 weeks after γδT infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival time(DFS) | γδT cell infusion treatment of CR/CRi patients from the beginning of γδT cell infusion treatment to the first disease recurrence or death from any cause | about 2 years after γδT infusion |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suning Chen, Ph.D | Contact | 13814881746 | chensuning@sina.com | |
| Xiaofei Yang, Ph.D | Contact | 18962156841 | yangxiaofei1977@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Suning Chen, Ph.D | Hematology,The First Affiliaated Hospital Of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.188 Shizi Street | Recruiting | Suzhou | Jiangsu | 215006 | China |
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| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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The time from the subject receiving γδT cell infusion treatment to death (for any reason)
| about 2 years after γδT infusion |
| Duration of remission after administration (DOR) | γδT cell infusion treatment has not reached CR/CRi before the treatment, the time from the first assessment of CR/CRi after administration to the first assessment of disease recurrence or progression or death from any cause | about 2 years after γδT infusion |
| D006425 |
| Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |