NCT02328885

Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Banc de Sang i Teixits · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	DLI of the 20 fraction of the UCBT	Administration of 20 fraction of the UCBT

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-03-22
• Completion: 2017-03-22
• First posted: 2014-12-31
• Last updated: 2021-12-08

Locations

5 sites across 1 country: Spain