The Influence of Thiopurine Methyltransferase Activity on Toxicity After High-dose Methotrexate in Childhood Acute Lymphoblastic Leukemia

NCT01886651 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 411

Last updated 2013-06-26

No results posted yet for this study

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 maintenance therapy for children with ALL.

Hypothesis of the study: Patients with TPMT activity compatible with TPMT low activity polymorphisms have an increased risk of toxicity following high-dose methotrexate (HDM) compared to children with normal TPMT activity.

Conditions

Sponsors & Collaborators

  • Nordic Society for Pediatric Hematology and Oncology

    collaborator OTHER
  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Kjeld Schmiegelow, M.D. · Rigshospitalet, Denmark

Eligibility

Min Age
1 Year
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01886651 on ClinicalTrials.gov