Defibrotide Dose-escalation for SOS Post-HSCT

Sinusoidal Obstruction Syndrome Clinical Trial

Official title:
A Phase II Intrapatient Open-Label Dose Escalation Trial of Defibrotide in Hematopoietic Cell Transplantation (HCT) Recipients With Sinusoidal Obstructive Syndrome (SOS) Post-HCT Associated With Either Renal and/or Pulmonary Dysfunction With Either Refractory or Progressive Disease Following Defibrotide Therapy

Status Recruiting

Clinical Trial Summary

This research study is being done to determine the safety and tolerability of increasing doses of defibrotide within a single patient with sinusoidal obstructive syndrome (SOS)/veno-occlusive disease (VOD) after hematopoietic cell transplantation (HCT) associated with either kidney and/or lung impairment that has not obtained a complete response (CR) or progressed in severity with standard doses of defibrotide.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05987124
Study type	Interventional
Source	New York Medical College
Contact	Mitchell Cairo, MD
Phone	914-594-2150
Email	mitchell_cairo@nymc.edu
Status	Recruiting
Phase	Phase 2
Start date	March 20, 2024
Completion date	August 1, 2027

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04141735` - Detection of Sinusoidal Obstruction Syndrome With Ultrasound After Allogeneic HSCT
Completed	`NCT03858530` - Ultrasound Elastography to Predict Development of SOS	Phase 4
Recruiting	`NCT04313036` - 5-day Defibrotide Treatment for Hepatic SOS/VOD	Phase 2
Completed	`NCT00885950` - Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants	N/A
Completed	`NCT02483481` - Using Ultrasound Elastography to Predict Development of SOS	N/A
Recruiting	`NCT06054451` - Clinical Diagnosis and Pathological Spectrum of Porto-sinusoidal Vascular Disease in India
Completed	`NCT03426358` - Liver Stiffness Measurement Predicts VOD/SOS Development (ELASTOVOD ITALIAN MULTICENTRIC STUDY)	N/A
Not yet recruiting	`NCT06258525` - SAMe in Prevention of Oxaliplatin-associated Liver Injury	Phase 2
Withdrawn	`NCT03963999` - Validating Ultrasound Biomarkers for Hepatic Sinusoidal Obstruction Syndrome in Pediatric Hematopoietic Cell Transplant Patients	Phase 4
Recruiting	`NCT03865589` - Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome	N/A
Completed	`NCT03132337` - Sinusoidal Obstruction Syndrome for Stem Cell Transplant Patients Biomarker Study