Actively Recruiting
Defibrotide Dose-escalation for SOS Post-HSCT
Led by New York Medical College · Updated on 2026-04-15
20
Participants Needed
1
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Defibrotide Dose-escalation for SOS Post-HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who received hematopoietic cell transplantation (auto or allograft)
- Diagnosis of SOS/VOD with kidney and/or lung dysfunction by Cairo/Cooke criteria
- Patients with no complete response after at least 14 or 21 days of standard defibrotide (25 mg/kg/day)
- Patients with progressive disease after at least 7 days of standard defibrotide (25 mg/kg/day)
- Age between 1 month and 75 years
You will not qualify if you...
- Patients who did not receive hematopoietic cell transplantation
- Use of systemic anticoagulation except for specific line management or dialysis
- Active bleeding of grade 2 or higher
- History of severe anaphylaxis (Grade III/IV) related to defibrotide
- Female patients who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
New York Medical College
Vallhala, New York, United States, 10595
Actively Recruiting
Research Team
M
Mitchell Cairo, MD
CONTACT
L
Lauren Harrison, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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