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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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For micro residual disease (MRD) positive patients who have undergone at least 2 cycles chemotherapies for their CD19+ B-cell malignancies, there would be much more risks for them to receive hematological stem cell transplantation (HSCT) than MRD- patients. In order to reduce HSCT-related adverse events for these kind of patients, investigators plan to conduct CAR-T therapies on them first to make them achieve MRD- statuses, and then transfer them to HSCT.
In order to improve prognoses for MRD+ patients who have undergone at least 2 cycles chemotherapies, patients will receive CAR-T therapy before HSCT, once they achieve MRD- remissions, they will subsequently receive HSCT if there are no contraindications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of CAR-T therapy and HSCT | Experimental | After patients achieve MRD- remissions through Second generation CAR-T cells, they will subsequently receive hematological stem cell transplantations within 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Second generation CAR-T cells | Genetic | Patients receive CD19 CAR-T cells transduced with a lentiviral vector on days 0, 1, and 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of study related adverse events | defined as >= Grade 3(NCI CTCAE version 4.03) signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment | 200 days from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with an MRD negative complete remission after CAR-T therapy and HSCT | the efficacy of the combination of CAR-T therapy and HSCT will be estimated based on the number of participants who have an MRD negative (flow cytometry) bone marrow aspirate following the treatment | 2 years from enrollment |
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Inclusion Criteria:
The patient is pathologically and histologically confirmed as CD19 + B cell tumors, and has no effective treatment options currently, such as chemotherapy or autologous hematopoietic stem cell transplantation (auto-HSCT); or patients voluntarily choose CD19 CAR-T cells as a first treatment;
The patient is MRD+ (<10%) after at least two cycles of chemotherapies.
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 | Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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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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| The First People's Hospital of Yuhang District |
| OTHER |
The only one group of patients will receive the combination of CAR-T therapy and HSCT.
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| Hematological stem cell transplantation | Procedure | Patients receive hematological stem cell transplantations within 3 months after they achieve MRD- remissions after CAR-T therapies. |
|
| 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 |