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

Are you eligible to participate in this study?

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

  • Conditions: stem cell transplant
  • Age: Between 0 - 18 Years
  • Gender: Male or Female

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

Recruitment Status

Open

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