Defibrotide Dose-escalation for SOS Post-HSCT

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 20, 2024

Primary Completion Date

August 1, 2026

Study Completion Date

August 1, 2027

Conditions
Sinusoidal Obstruction SyndromeVeno-occlusive Disease
Interventions
DRUG

Defibrotide

HCT recipients with SOS/VOD and renal and/or pulmonary dysfunction with either PR after 21 days of standard doses of defibrotide (25mg/kg/day) or SD, after 14 days of standard doses of defibrotide (25mg/kg/day) progressive disease after 7 days on defibrotide (25mg/kg/day) will undergo intra-patient dose escalation every 4 days until a complete response is obtained up until the highest dose level of 100mg/kg/day at which point an endpoint of CR, PR or SD will be sought(Maximum of 4 dose levels). Defibrotide will be administered in D5W or 0.9% NaCl via IV infusion over 2 hours q6 hours.

Trial Locations (1)

10595

RECRUITING

New York Medical College, Valhalla

Sponsors
All Listed Sponsors
lead

New York Medical College

OTHER