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Slow accrual
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The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alloreactive NK cell infusion | Experimental | Escalating doses of alloreactive NK cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CliniMACS CD34 Reagent System | Device | Alloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the maximum-tolerated dose (MTD) of highly-purified alloreactive NK cells infused following haplotype-mismatched, KIR ligand-mismatched transplants in patients with refractory hematological malignancies. | through Day 128 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess toxicity associated with the infusion of alloreactive NK cells | through Day 128 | |
| Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells. | through Day 128 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherif Farag, MD, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses. |
| through Day 128 |
| Describe the frequency and type of infections occurring within the first year following transplantation. | through Day 128 |
| Describe immune reconstitution following transplantation. | through Day 128 |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007945 | Leukemia, Lymphoid |
| D009190 | Myelodysplastic Syndromes |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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