Pilot, multicentric, open-label, single-arm, phase I-II clinical trial to evaluate the safety and efficacy of a novel Umbilical Cord Blood Transplantation (UCBT) platform, that consists of a UCBT of the 80 fraction, followed by a Donor Lymphocyte Infusion (DLI) of the 20 fraction (between 60 and 90 days after transplantation).
Multicenter, open-label, single-arm, phase I-II pilot study in which a minimum of 20 patients will enter the study with the primary objective to assess the safety and secondary objective to assess efficacy in relation to immune reconstitution followed by a new platform of treatment consisting of initial cord blood unit 80 fraction transplantation, followed by a prophylactic donor lymphocyte infusion (DLI) of the fraction 20 of the cord blood unit. The second infusion will take place between 60 and 90 days after transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Administration of 20 fraction of the UCBT
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Sant Pau
Barcelona, Spain
Hospital Vall Hebron
Barcelona, Spain
Safety assessment
Adverse events
Time frame: 1 year
Immune reconstitution:
Subpopulations of Lymphocytes T: CD4 and CD8
Time frame: 1 year
Immunological reconstitution:
NK cells
Time frame: 1 year
Immune regeneration
Lymphocytes B
Time frame: 1 year
Infections in treated patients
Incidence of infections
Time frame: 1 year
Infections in the treated patients
Type of infections
Time frame: 1 year
Relapse of leukemia
Incidence of relapse
Time frame: 1 year
Survival curves
Global and disease-free survival
Time frame: 1 year
Mortality
Incidence of early and late mortality
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital de Sant Pau
Barcelona, Spain