Myeloablative Conditioning, Prophylactic Defibrotide and Haplo AlloSCT for Patients With Sickle Cell Disease

Clinical Trial
Study Details
Enrollment
40
Interventions
Description

defibrotide will be given prophylactically prior to AlloSCT to determine if it decreases the incidence of SOS in this high risk population, and determine that it is safe and feasible to give along with myeloimmunoablative therapy and allogeneic transplant.

Name
Defibrotide
Type
Drug
Phase
Phase 2
Status
RECRUITING
Study ID #
NCT02675959
Study Type
Interventional
Summary

This is a follow-up trial to NYMC 526 (NCT01461837) to assess the safety, efficacy and toxicity of administering Defibrotide prophylaxis for high-risk sickle cell or beta thalassemia patients undergoing a familial haploidentical or MUD allogeneic stem cell transplantation with CD34 enrichment and T-cell addback. This patient population historically has a risk of developing sinusoidal obstructive syndrome (SOS) and Defibrotide has demonstrated efficacy in treatment of SOS. The Funding Source is FDA OOPD.

Study Overview
Conditions
Contacts and Locations
Locations
Facility

University of California Los Angeles
Los Angeles, California 90095
United States

GeoPoint
34.05223, -118.24368
Status
Recruiting
Facility

University of Florida
Gainesville, Florida 32610-0278
United States

GeoPoint
29.65163, -82.32483
Status
Recruiting
Facility

New York Medical College
Valhalla, New York 10595
United States

GeoPoint
41.07482, -73.77513
Status
Recruiting
Facility

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States

GeoPoint
43.0389, -87.90647
Status
Recruiting