Relapsed/Refractory Paediatric Acute Leukaemia Clinical Trial
— LYDIAOfficial title:
"LANK-2": Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia
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
| Status | Completed |
| Enrollment | 13 |
| Est. completion date | September 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 23 Years |
| Eligibility |
Inclusion Criteria: 1. Patients between 0 and 23 years of age with diagnosis of acute lymphoblastic leukemia, in second relapse situation, posttransplant relapse or refractary, or 2. Patients between 0 and 23 years of age with diagnosis of acute myeloblastic leukemia, relapsed or refractary. (Patient must meet inclusion criteria 1 or 2) 3. Lansky index > 60% 4. Mild (<2) functional organs alteration (hepatic, renal, respiratory) according to National Cancer Institute criteria (NCI CTCAE v4). 5. Left ventricular ejection fraction > 39% 6. To grant informed consent in accordance with the current legal regulations. 7. Presence of a compatible haploidentical donor (father or mother or brother). Exclusion Criteria: 1. Patients with history of bad therapeutical compliance 2. Patients not valid after psycho-social evaluation 3. Positive HIV serology |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital 12 de Octubre | Madrid | |
| Spain | Hospital Infantil Universitario La Paz | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Universitario La Paz |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections | End of infusion and follow-up (2 months and 1 year) | Yes | |
| Secondary | Days of hematological recovery (neutrophils >500/microL, lymphocytes >250/microL and platelets >50.000/microL), days of hospitalization, in each cycle Immune | End of infusion and follow-up (2 months and 1 year) | No | |
| Secondary | 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) | No | |
| Secondary | 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) | No |