NCT00268528

Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission

Completed Last updated 7 July 2020

What this trial tests

trial testing Compliance Monitoring in Childhood Acute Lymphoblastic Leukemia in Remission in 720 participants. Completed in 30 June 2020.

Timeline

30 May 2005

Primary endpoint
5 March 2012

30 June 2020

Quick facts

Lead sponsor	Children's Oncology Group
Status	Completed
Study type	OBSERVATIONAL
Enrollment	720
Start date	30 May 2005
Primary completion	5 March 2012
Estimated completion	30 June 2020
Sites	135 locations across Canada, United States, Australia

Drugs / interventions tested

• Compliance Monitoring
• Laboratory Biomarker Analysis — full drug profile →
• Mercaptopurine (MERCAPTOPURINE) — full drug profile →
• Methotrexate — full drug profile →
• Questionnaire Administration
• Study of Socioeconomic and Demographic Variables

Conditions studied

• Childhood Acute Lymphoblastic Leukemia in Remission — all drugs for Childhood Acute Lymphoblastic Leukemia in Remission →

Sponsor

Children's Oncology Group — full company profile →

Who can join

Under 21, any sex, with Childhood Acute Lymphoblastic Leukemia in Remission. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical trial is assessing compliance with long-term mercaptopurine treatment in young patients with acute lymphoblastic leukemia in remission. Assessing why young patients who have acute lymphoblastic leukemia may not take their medications as prescribed may help identify ways to assist them in taking their medications more consistently and may improve long-term treatment outcomes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Inherited NUDT15 variant is a genetic determinant of mercaptopurine intolerance in children with acute lymphoblastic leukemia.
   Yang JJ, Landier W, Yang W, Liu C, et al · · 2015 · cited 327× · PMID 25624441 · DOI 10.1200/jco.2014.59.4671
2. 6MP adherence in a multiracial cohort of children with acute lymphoblastic leukemia: a Children's Oncology Group study.
   Bhatia S, Landier W, Hageman L, Kim H, et al · · 2014 · cited 157× · PMID 24829202 · DOI 10.1182/blood-2014-01-552166
3. Systemic Exposure to Thiopurines and Risk of Relapse in Children With Acute Lymphoblastic Leukemia: A Children's Oncology Group Study.
   Bhatia S, Landier W, Hageman L, Chen Y, et al · · 2015 · cited 113× · PMID 26181173 · DOI 10.1001/jamaoncol.2015.0245
4. Genomewide Approach Validates Thiopurine Methyltransferase Activity Is a Monogenic Pharmacogenomic Trait.
   Liu C, Yang W, Pei D, Cheng C, et al · · 2017 · cited 36× · PMID 27564568 · DOI 10.1002/cpt.463
5. Comparison of self-report and electronic monitoring of 6MP intake in childhood ALL: a Children's Oncology Group study.
   Landier W, Chen Y, Hageman L, Kim H, et al · · 2017 · cited 35× · PMID 28153823 · DOI 10.1182/blood-2016-07-726893
6. Race, Genotype, and Azathioprine Discontinuation : A Cohort Study.
   Dickson AL, Daniel LL, Jackson E, Zanussi J, et al · · 2022 · cited 29× · PMID 35724382 · DOI 10.7326/m21-4675
7. Mercaptopurine Ingestion Habits, Red Cell Thioguanine Nucleotide Levels, and Relapse Risk in Children With Acute Lymphoblastic Leukemia: A Report From the Children's Oncology Group Study AALL03N1.
   Landier W, Hageman L, Chen Y, Kornegay N, et al · · 2017 · cited 28× · PMID 28339328 · DOI 10.1200/jco.2016.71.7579
8. Poverty and relapse risk in children with acute lymphoblastic leukemia: a Children's Oncology Group study AALL03N1 report.
   Wadhwa A, Chen Y, Hageman L, Hoppmann A, et al · · 2023 · cited 21× · PMID 37070673 · DOI 10.1182/blood.2023019631