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| Name | Class |
|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Jingzhou Central Hospital | OTHER |
| Xiangyang Central Hospital | OTHER |
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This is the second stage of the previous anti-CD19 CAR-T therapy (NCT02965092). The study aims to evaluate the safety and efficacy of consolidative allo-HSCT following CAR-T therapy in patients with relapsed or refractory B cell Malignancies.
Anti-CD19 CAR-T therapy has been confirmed effective for relapsed/refractory B-cell malignancies. However, its ability to keep patients in maintained remission is limited. In order to keep patients in long-term remissions, patients who had achieved MRD-negative complete remissions through CAR-T therapy (NCT02965092) will, on their own accord, receive allo-HSCT if there are no previous HSCT, contraindications, and other restrictions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consolidative allo-HSCT following CAR-T therapy | Experimental | Patients who had achieved MRD-negative complete remissions through CAR-T therapy (NCT02965092) will, on their own accord, receive allo-HSCT if there are no previous HSCT, contraindications, and other restrictions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic hematological stem cell transplantation | Procedure | Patients receive allogeneic hematological stem cell transplantation after they achieve MRD- CR through CAR-T therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | To evaluate the safety of anti-CD19 CAR-T therapy bridging to allo-HSCT. Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | OS was calculated from the date of inclusion to death or last follow-up (censored). | 5 years |
| Event-free survival | EFS was calculated from the date of inclusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit (censored). |
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Inclusion Criteria:
The patient is pathologically and histologically confirmed as CD19 + B cell malignancies, and has achieved MRD-negative CR through CAR-T therapy (NCT02965092);
B cell hematological malignancies include the following three categories:
< 70 years old;
Expected survival time > 6 months;
Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;
Voluntarily participate in this experiment and sign informed consent by themselves, or legally authorized representative.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YU HU, M.D., Ph.D | Contact | 86-13986183871 | dr_huyu@126.com | |
| HENG MEI, M.D., Ph.D | Contact | 86-13886160811 | mayheng@126.com |
| Name | Affiliation | Role |
|---|---|---|
| YU HU, M.D., Ph.D | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40195173 | Derived | Du M, Mayombo RTM, Liu J, Zhang Y, Liao D, Hu Y, Mei H. The impact of obesity and its related underlying diseases on cytokine release syndrome and the efficacy of CAR-T therapy in treating B-cell malignancies. Ann Hematol. 2025 Mar;104(3):1887-1895. doi: 10.1007/s00277-025-06338-6. Epub 2025 Apr 8. |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| People Hospital Of Yichang |
| UNKNOWN |
Patients receive consolidative allo-HSCT following CAR-T therapy.
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| 5 years |
| Relapse-free survival | RFS was calculated from the date of inclusion to relapse or last visit (censored). | 5 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |