Spots Global Cancer Trial Database for Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation

Official Title: Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation

Study ID: NCT02328885

Conditions

Leukemia

Interventions

DLI of the 20 fraction of the UCBT

Study Description

Brief 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).

Detailed 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.