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Sinusoidal Obstruction Syndrome for Stem Cell Transplant Patients Biomarker Study | Clinical Trials | Clareo Health

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Sinusoidal Obstruction Syndrome for Stem Cell Transplant Patients Biomarker Study

Biomarkers of Endothelial Dysfunction in Pediatric Patients Receiving High Intensity Chemotherapy/Irradiation

NCT03132337•Indiana University

Summary

The goal of this is to learn more about stem cell transplant and complications that some people have after their transplants, in particular sinusoidal obstruction syndrome (SOS), also called veno-occlusive disease of the liver.

Detailed Description

This is a multicenter, prospective, observational trial. We will measure biomarkers and determine thresholds that will predict increased risk for SOS in pediatric patients receiving HCT or high intensity chemotherapy/irradiation with the future goal of a randomized, interventional, open-label, multicenter trial that will test the preemptive use of defibrotide for prevention of SOS in an enriched high-risk population.

Eligibility

Age

0 - 25 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≤ 25 years undergoing HCT for any reason who fulfill any ONE (1) of the following criteria:
•1. History of hepatic disease as defined by:
•1. Viral hepatitis (i.e., hepatitis C virus \[HCV\])
•2. Liver tumor before HCT
•3. Hepatic fibrosis or cirrhosis before HCT as proven by liver biopsy
•4. High aspartate aminotransferase (AST) (\> 2x ULN) before HCT (pre-transplant evaluation)
•5. High alanine transaminase (ALT) (\> 2x ULN) before HCT
•6. High bilirubin (\> 1.2x ULN) before HCT
•2. HCT high-risk features including:
•a. Conditioning with high-risk modalities including: i. Busulfan (BU)-containing regimen particularly with oral BU + cyclophosphamide ii. TBI-containing regimen, particularly cyclophosphamide + total-body irradiation (TBI) b. ≥ 2 HCT c. Allo-HCT for leukemia \> or = second relapse d. Unrelated donor (URD) HCT e. Human leukocyte antigen (HLA) mismatch HCT (less than 10 of 10 for bone marrow/peripheral blood stem cell \[BM/PBSC\] or anything less than 6 of 6 for UCB) f. Use of sirolimus + tacrolimus prophylaxis for GVHD
+11 more criteria

Exclusion Criteria

•Patients who are transplanted but do not fulfill any of the above mentioned criteria.

Locations (4)

Children's National Medical Center

Washington D.C., District of Columbia, United States

Indiana University

Indianapolis, Indiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Baylor College of Medicine

Houston, Texas, United States

Key Dates

Start Date

April 1, 2017

Primary Completion Date

January 14, 2021

Completion Date

January 14, 2021

Last Updated

December 19, 2023

Enrollment

ACTUAL participants

Conditions

Sinusoidal Obstruction Syndrome

Interventions

Serial Blood Draws

OTHER

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NCT06054451

Portal HypertensionBudd-Chiari Syndrome+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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