Status:
COMPLETED
The Influence of Thiopurine Methyltransferase Activity on Toxicity After High-dose Methotrexate in Childhood Acute Lymphoblastic Leukemia
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Nordic Society for Pediatric Hematology and Oncology
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-15 years
Brief Summary
The purpose of this study is to explore the impact of thiopurine methyltransferase (TPMT) activity on the risk of HDM-related bone marrow- and hepatotoxicity and treatment interruptions during mainten...
Detailed Description
High-dose methotrexate (HDM) given concurrently with oral 6-mercaptopurine (6MP) may be followed by myelotoxicity, which may necessitate treatment interruption and thus interfere with the efficacy of ...
Eligibility Criteria
Inclusion
- included in the NOPHO ALL92 protocol
- available TPMT phenotype
- treated at least once with HD-MTX 5.0 g/m2 (+- 10%) during maintenance therapy
- at least one available measurement on blood counts or alanine aminotransferase levels 28 days after HD-MTX
Exclusion
- HR ALL
- children with Down Syndrome
- Events during maintenance therapy
- TPMT deficiency
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT01886651
Start Date
July 1 2011
End Date
February 1 2012
Last Update
June 26 2013
Active Locations (1)
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1
Kjeld Schmiegelow
Copenhagen, Denmark, 2100