Document Detail


Genotoxicity associated with hydroxyurea exposure in infants with sickle cell anemia: results from the BABY-HUG Phase III Clinical Trial.
MedLine Citation:
PMID:  22012708     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The laboratory and clinical benefits of hydroxyurea therapy for children with sickle cell anemia (SCA) are well recognized, but treatment in young patients is limited in part by concerns about long-term genotoxicity, and specifically possible carcinogenicity.
PROCEDURE: The Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) was a multicenter double-blinded placebo-controlled randomized clinical trial (NCT00006400) testing whether hydroxyurea could prevent chronic organ damage in very young patients with SCA. An important secondary objective was the measurement of acquired genotoxicity using three laboratory assays: chromosomal karyotype, illegitimate VDJ recombination events, and micronucleated reticulocyte formation.
RESULTS: Our data indicate that hydroxyurea treatment was not associated with any significant increases in genotoxicity compared to placebo treatment.
CONCLUSIONS: These data provide additional support to the safety profile of hydroxyurea for young patients with SCA, and suggest that genotoxicity in this patient population is low.
Authors:
Patrick T McGann; Jonathan M Flanagan; Thad A Howard; Stephen D Dertinger; Jin He; Anita S Kulharya; Bruce W Thompson; Russell E Ware;
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2011-10-19
Journal Detail:
Title:  Pediatric blood & cancer     Volume:  59     ISSN:  1545-5017     ISO Abbreviation:  Pediatr Blood Cancer     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-06-12     Completed Date:  2012-09-17     Revised Date:  2013-08-15    
Medline Journal Info:
Nlm Unique ID:  101186624     Medline TA:  Pediatr Blood Cancer     Country:  United States    
Other Details:
Languages:  eng     Pagination:  254-7     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 Wiley Periodicals, Inc.
Affiliation:
Baylor College of Medicine, Houston, Texas, USA. mcgann@bcm.edu
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MeSH Terms
Descriptor/Qualifier:
Anemia, Sickle Cell / drug therapy*,  genetics*
Antisickling Agents / therapeutic use*
DNA Damage / drug effects*,  genetics*
Double-Blind Method
Follow-Up Studies
Humans
Hydroxyurea / therapeutic use*
Infant
Prognosis
V(D)J Recombination
Grant Support
ID/Acronym/Agency:
N01-HB-07150/HB/NHLBI NIH HHS; N01-HB-07160/HB/NHLBI NIH HHS; N01HB07160/HL/NHLBI NIH HHS; U54 HL070590-07/HL/NHLBI NIH HHS; U54-HL070590/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Antisickling Agents; 127-07-1/Hydroxyurea
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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