Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation

Status Completed

Clinical Trial Summary

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).

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Leukemia

Clinical Trial Details

NCT number	NCT02328885
Study type	Interventional
Source	Banc de Sang i Teixits
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	July 2014
Completion date	March 22, 2017

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