Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma
NCT ID: NCT01944982
Last Updated: 2016-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
7 participants
INTERVENTIONAL
2013-07-31
2016-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Activated natural killer cells
Activated natural killer cells
Expanded haploidentical natural killer cells (NKAEs)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Expanded haploidentical natural killer cells (NKAEs)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Lansky Index \> 60%.
* Left ventricular ejection fraction \> 39%.
* Negative HIV serology.
* Provide informed consent in accordance with current legislation.
Exclusion Criteria
* Patients not valid after psycho-social evaluation
* Severe (4) functional organ disorders (hepatic, renal, respiratory) according to NCI CTCAE v3 criteria
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Antonio Perez-Martinez
Doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Antonio Pérez-Martínez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Service of Pediatric Hematology-Oncology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pediatric Hematology-Oncology; Hospital Infantil Universitario La Paz
Madrid, Madrid, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-000054-63
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HNJ-NKAES-2012
Identifier Type: -
Identifier Source: org_study_id