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| Name | Class |
|---|---|
| Hebei Yanda Ludaopei Hospital | OTHER |
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This trial will evaluate the effectiveness and safety of haploid donor-derived in vitro activated natural killer(NK) cells infusion for Treating acute myeloid leukemia Patients With minimal residual disease.
Patients of acute myeloid leukemia after chemotherapy with MRD(minimal residual disease) will receive NK cell infusion combined with consolidation chemotherapy. The bone marrow morphology and MRD remission of the patients will be observed 15 days after the same treatment. All patients will be followed up for 1 year.
NK cells are prepared in Beijing iCELL Biotechnology Co.,Ltd, which is subsidiary to Shanghai iCELL Biotechnology Co.,Ltd.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| haploid allogeneic NK cell therapy | Experimental | haploid allogeneic NK cell therapy with chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| haploid allogeneic NK cell therapy | Biological | NK cells will be intravenously infused to the patient for 2 days, with following subcutaneously injection of Interleukin-2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Residual Disease (MRD) | MRD-negative is defined as <0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as >=0.1% blasts with leukemia-associated phenotype detected by flow cytometry. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Evaluation of toxicities defined as any CTCAE (v. 4.03) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang ZHU | Contact | +86-15900398802 | zhujiang@icell.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xian Zhang | Hebei Yanda Ludaopei Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Yanda Ludaopei Hospital | Recruiting | Langfang | Hebei | 065201 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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haploid allogeneic NK cell therapy with chemotherapy
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |