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This phase I/II study the side effects and efficacy of natural killer cells after donor stem cell transplant and how they treat patients with myeloid malignancies or lymphoproliferative disorders. Investigators expanded NK cells ex vivo with a non-feeder cell regimen to avoid the risk of infusion of feeder cells with expanded NK cells. Investigators infuse NK cells after myeloablative conditioning therapy. These cells may help decrease relapse of malignant disease, severe graft versus host disease, reactivation of certain viruses, and, therefore, prolong the survival of participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | MYELOABLATIVE CONDITIONING REGIMEN: Patients with myeloid malignancies receive busulfan on days -7 to -4, fludarabine IV over 1 hour on days -7 to -3, cytarabine IV over 4 hours on days -7 to -3. Patients with lymphoproliferative disorders receive busulfan on day -7 to -4, cladribine IV over 1 hour on days -7 to -3, gemcitabine IV over 4 hours on days -7 and -3. TRANSPLANT: Patients undergo PBSC transplant on day 0. POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, cyclosporin IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO BID beginning on day 5 for 30 days. NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated doses (MTD) of natural killer (NK) cells | Primary Outcome Measures | Up to day 70 post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 100-day treatment related mortality | Will be defined as death due to any cause without disease recurrence within 100 days post stem cell transplant (SCT). The method of Thall and Sung will be used, based on an historical rate of 35%. | Up to 100 days post-transplant |
| Overall survival |
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Inclusion Criteria:
11. Patient or patient's legal representative, parent(s), or guardian should provide written informed consent; the permission of a minor if participant's age is at least seven and less than eighteen years
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Ji, MD | Contact | 86-28-85422373 | jieji@scu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jie Ji, MD | West China Hospital, Sichuan Uiversity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610044 | China |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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intervention: Expanded NK cells
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Will be estimated using the Kaplan-Meier method, and distributions will be compared using log-rank tests. |
| Up to 2 years post-transplant |
| Relapse-free survival | Will be estimated using the Kaplan-Meier method, and distributions will be compared using log-rank tests. | Up to 2 years post-transplant |
| Time to engraftment | Will be estimated using the Kaplan-Meier method, and distributions will be compared using log-rank tests. | Up to 2 years post-transplant |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |