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

NCT01886651 | Completed

• 1 other identifier: NOPHO ALL92 study HDM TPMT
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 1

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 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

Acute Lymphoblastic Leukemia

Keywords

acute lymphoblastic leukemia; child; 6-mercaptopurine; methotrexate

Outcome Measures

Primary Outcomes (1)

• Toxicity of treatment, degree of myelo- and hepatotoxicity

  7-28 days after high-dose methotrexate

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study cohort was based on patients enrolled in the NOPHO ALL92 protocol, where 97% of all eligible patients were included. Participation in this study was on the basis of TPMT status that was randomly missing.

You may qualify if:

• 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

You may not qualify if:

• HR ALL
• children with Down Syndrome
• Events during maintenance therapy
• TPMT deficiency

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Nordic Society for Pediatric Hematology and Oncology: collaborator

Study Sites (1)

Kjeld Schmiegelow

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood stored for a subset of patients

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kjeld Schmiegelow, M.D.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 21, 2013
• First Posted: June 26, 2013
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 26, 2013

Record last verified: 2013-06

Locations

DK (1)