Defibrotide Dose-escalation for SOS Post-HSCT

Recruiting Phase 2 Interventional Study
Sinusoidal Obstruction Syndrome Veno-occlusive Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 Month – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
New York Medical College · Other
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About This Trial
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 o…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * HCT recipients (Auto or Allograft) * SOS/VOD as defined by Cairo/Cooke Diagnostic criteria (1) (Table 3) with either renal and/or pulmonary dysfunction as defined by Cairo/Cooke Grading criteria (1) (Appendix I). * Unresponsive to standard defibrotide therapy as defined by at …
Contacts

Mitchell Cairo, MD

914-594-2150

mitchell_cairo@nymc.edu

CONTACT

Lauren Harrison, MSN

617-285-7844

lauren_harrison@nymc.edu

CONTACT