Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma
Conditions
Keywords
Immunotherapy, NKAEs, Expanded haploidentical natural killer cells, Activated natural killer cells
Brief summary
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.
Interventions
BIOLOGICALExpanded haploidentical natural killer cells (NKAEs)
Sponsors
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 0 and 21 years with relapsed or refractary acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. * Lansky Index \> 60%. * Left ventricular ejection fraction \> 39%. * Negative HIV serology. * Provide informed consent in accordance with current legislation.
Exclusion criteria
* Patients with a history of poor compliance. * Patients not valid after psycho-social evaluation * Severe (4) functional organ disorders (hepatic, renal, respiratory) according to NCI CTCAE v3 criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile (number of AEs per patient) | Two months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 2 months | Objective response rate according to cytomorphic and by minimal residual disease criteria (cytometry and/or real time PCR) |
| days of isolation | 2 months | — |
| Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections | During 14 months | — |
| time to hematological recovery (days) | 2 months | hematological recovery: neutrophils \>500/mm3, lymphocytes \>250/mm3 and platelets \>50.000/mm3) |
| days of hospitalization in each cycle | 2 months | — |
Countries
Spain
Outcome results
None listed