"LANK-2": Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia
NCT ID: NCT02074657
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
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2014-04-30
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Activated natural killer cells
Activated and expanded natural killer cells (NKAEs)
Activated and expanded natural killer cells (NKAEs) from haploidentical donor
Interventions
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Activated and expanded natural killer cells (NKAEs)
Activated and expanded natural killer cells (NKAEs) from haploidentical donor
Eligibility Criteria
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Inclusion Criteria
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
2. Patients not valid after psycho-social evaluation
3. Positive HIV serology
23 Years
ALL
No
Sponsors
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Hospital Universitario La Paz
OTHER
Responsible Party
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Antonio Pérez Martínez
MD, Servicio de Hemato-Oncología Pediátrica
Principal Investigators
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Antonio Pérez-Martínez, MD, PhD
Role: STUDY_CHAIR
Hospital Infantil Universitario La Paz
Locations
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Hospital 12 de Octubre
Madrid, Madrid, Spain
Hospital Infantil Universitario La Paz
Madrid, Madrid, Spain
Countries
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References
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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
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2012-005146-38
Identifier Type: -
Identifier Source: org_study_id