WHO ICTRP trial

Phase I/IIa clinical trial on the safety and preliminary efficacy of…

EUCTR2019-003362-41-IT · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2019-003362-41-IT
Public title Phase I/IIa clinical trial on the safety and preliminary efficacy of donor-derived anti-leukemia cytotoxic T lymphocytes for the prevention of leukemia relapse in children given haploidentical hematopoietic stem cell transplantation
Scientific title Phase I/IIa clinical trial on the safety and preliminary efficacy of donor-derived anti-leukemia cytotoxic T lymphocytes for the prevention of leukemia relapse in children given haploidentical hematopoietic stem cell transplantation - Anti-leukemia T cell therapy after haplo-HSCT
Primary sponsor FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Italy
Conditions Leukemia relapse prevention given haploidentical hematopoietic stem cell transplantation MedDRA version: 21.1 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant…
Interventions Product Name: linfociti T citotossici anti-leucemia Product Code: [CTL anti-leucemia] Pharmaceutical Form: Suspension for injection Current Sponsor code: ND Concentration unit: IU/kg international unit(s)/kilogram Concentration type: range…
Registration date Jul 10, 2020
Target size 15
Secondary IDs Leuk-CTL-001
Registry page clinicaltrialsregister.eu

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