Pilot Study: Infusion of off-the-shelf ex vivo expanded cryopreserved progenitor cells (dilanubicel) in the setting of single cord blood transplantation for patients with hematologic malignancies
Single cord blood study (dilanubicel) - p9910
What is the goal of the study?
The primary objective of this study is to show that single unit cord blood transplantation augmented with a single dose of dilanubicel is not associated with an excess of graft failure. 1. Primary graft failure/rejection as defined by no neutrophil recovery by day 45 (regardless of donor chimerism) or autologous recovery (neutrophil recovery but < 10% donor chimerism in blood and BM) by day 45. Secondary Objectives 1. Examine the safety and toxicity of infusing dilanubicel. 2. Evaluate neutrophil and platelet engraftment. For definitions/criteria, see Section 12. 3. Determine incidence of acute GVHD at day 100 and chronic GVHD at 1 and 2 years. 4. Determine non-relapse mortality at day 100 and 180
Who can participate in the study?
Please contact the study team listed below to learn more.