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To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in children, adolescents and young adults with relapsed or refractary acute leukemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activated natural killer cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated and expanded natural killer cells (NKAEs) | Biological | Activated and expanded natural killer cells (NKAEs) from haploidentical donor |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of activated and expanded NK cell (NKAE) immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute leukemia | Number of patients with adverse events according to NCI-CTCAE v4.0 CRITERIA as a measure of safety and tolerability | 2 months after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections | End of infusion and follow-up (2 months and 1 year) | |
| Days of hematological recovery (neutrophils >500/microL, lymphocytes >250/microL and platelets >50.000/microL), days of hospitalization, in each cycle Immune |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Pérez-MartÃnez, MD, PhD | Hospital Infantil Universitario La Paz | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital 12 de Octubre | Madrid | Madrid | 28041 | Spain | ||
| Hospital Infantil Universitario La Paz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29477379 | Derived | Vela M, Corral D, Carrasco P, Fernandez L, Valentin J, Gonzalez B, Escudero A, Balas A, de Paz R, Torres J, Leivas A, Martinez-Lopez J, Perez-Martinez A. Haploidentical IL-15/41BBL activated and expanded natural killer cell infusion therapy after salvage chemotherapy in children with relapsed and refractory leukemia. Cancer Lett. 2018 May 28;422:107-117. doi: 10.1016/j.canlet.2018.02.033. Epub 2018 Feb 23. |
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| End of infusion and follow-up (2 months and 1 year) |
| Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR) at the end of the treatment | End of infusion and follow-up (2 months and 1 year) |
| Immune reconstitution: Median of T-cell , B, NK, Natural Killer T cell (NKT) and dendritic cells count and subpopulations of T and NK lymphocytes (cel/microL) during posttreatment follow-up period. | End of infusion and follow-up (2 months and 1 year) |
| Madrid |
| Madrid |
| 28046 |
| Spain |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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