Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000054-63 | EudraCT Number |
Not provided
Not provided
The low recruitment rate makes it very difficult to complete the study within a reasonable period of time.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activated natural killer cells | Experimental | Activated natural killer cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expanded haploidentical natural killer cells (NKAEs) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile (number of AEs per patient) | Two months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections | During 14 months | |
| time to hematological recovery (days) | hematological recovery: neutrophils >500/mm3, lymphocytes >250/mm3 and platelets >50.000/mm3) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Antonio Pérez-MartÃnez, MD, PhD | Service of Pediatric Hematology-Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Hematology-Oncology; Hospital Infantil Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 months |
| days of hospitalization in each cycle | 2 months |
| Objective response rate | Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR) | 2 months |
| days of isolation | 2 months |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided