Biomarkers of endothelial dysfunction in pediatric patients receiving high intensity chemotherapy/irradiation

J
Jodi Skiles

Primary Investigator

Overview

The purpose of this study is to collect blood specimens and data from patients undergoing stem cell transplant.

Description

The purpose of this study is to collect blood specimens and data from patients undergoing stem cell transplant.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    stem cell transplant
  • Age: - 18 Years
  • Gender: All

Inclusion Criteria
Age ? 18 years undergoing HCT for any reason who fulfill any ONE (1) of the following criteria:
History of hepatic disease as defined by:
a. Viral hepatitis (i.e., hepatitis C virus [HCV])
b. Liver tumor before HCT
c. Hepatic fibrosis or cirrhosis before HCT as proven by liver biopsy
d. High aspartate aminotransferase (AST) (> 2x ULN) before HCT (pre-transplant evaluation)
e. High alanine transaminase (ALT) (> 2x ULN) before HCT
f. High bilirubin (> 1.2x ULN) before HCT
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. greater that of equal to 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
High-risk disease states including:
a. Juvenile myelo-monocytic chronic leukemia (JMML)
b. Primary hemophagocytic lymphohistiocytosis (HLH)
c. Adrenoleukodystrophy
d. Osteopetrosis
Other high-risk features including:
a. Prior treatment with gemtuzumab ozogamicin
b. Use of hepatotoxic drugs 1 month before HCT and during HCT
c. Iron overload (i.e., thalassemia/sickle cell) with serum ferritin > 1000ng/ml
d. Deficit of ATIII, T-PA (i.e., 30% normal values), and resistance to activated protein C if clinical indication (these values do not have to be specifically checked if no clinical history)
e. Young age 2 years but more than 1 month
Exclusion Criteria
Patients who are transplanted but do not fulfill any of the above mentioned criteria


Additional Information:

Updated on 09 Mar 2024. Study ID: 1701020549 (IUSCC-0586)

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