Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia
NCT ID: NCT04770922
Last Updated: 2023-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2021-02-23
2021-11-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Pediatric ALL patients on 6-mercaptopurine
Pediatric ALL patients treated with 6-mercaptopurine who did not experience neutropenia.
No interventions assigned to this group
Pediatric ALL patients on 6-mercaptopurine with neutropenia
Pediatric ALL patients treated with 6-mercaptopurine who experienced neutropenia.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Received 6-mercaptopurine
* Available biobank (bone marrow or blood) sample(s) from which deoxyribonucleic acid (DNA) can be extracted
* White blood cell (WBC) levels
Exclusion Criteria
* No biobank sample
* No WBC level
21 Years
ALL
No
Sponsors
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Stanford University
OTHER
Cipherome, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kathleen M Sakamoto, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Stephanie M Smith, MD
Role: STUDY_DIRECTOR
Stanford University
Locations
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Stanford University
Stanford, California, United States
Countries
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References
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Bhatia S, Landier W, Hageman L, Chen Y, Kim H, Sun CL, Kornegay N, Evans WE, Angiolillo AL, Bostrom B, Casillas J, Lew G, Maloney KW, Mascarenhas L, Ritchey AK, Termuhlen AM, Carroll WL, Wong FL, Relling MV. Systemic Exposure to Thiopurines and Risk of Relapse in Children With Acute Lymphoblastic Leukemia: A Children's Oncology Group Study. JAMA Oncol. 2015 Jun;1(3):287-95. doi: 10.1001/jamaoncol.2015.0245.
Park Y, Kim H, Choi JY, Yun S, Min BJ, Seo ME, Im HJ, Kang HJ, Kim JH. Star Allele-Based Haplotyping versus Gene-Wise Variant Burden Scoring for Predicting 6-Mercaptopurine Intolerance in Pediatric Acute Lymphoblastic Leukemia Patients. Front Pharmacol. 2019 Jun 11;10:654. doi: 10.3389/fphar.2019.00654. eCollection 2019.
Relling MV, Gardner EE, Sandborn WJ, Schmiegelow K, Pui CH, Yee SW, Stein CM, Carrillo M, Evans WE, Klein TE; Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium guidelines for thiopurine methyltransferase genotype and thiopurine dosing. Clin Pharmacol Ther. 2011 Mar;89(3):387-91. doi: 10.1038/clpt.2010.320. Epub 2011 Jan 26.
Yang JJ, Landier W, Yang W, Liu C, Hageman L, Cheng C, Pei D, Chen Y, Crews KR, Kornegay N, Wong FL, Evans WE, Pui CH, Bhatia S, Relling MV. Inherited NUDT15 variant is a genetic determinant of mercaptopurine intolerance in children with acute lymphoblastic leukemia. J Clin Oncol. 2015 Apr 10;33(11):1235-42. doi: 10.1200/JCO.2014.59.4671. Epub 2015 Jan 26.
Lennard L. Implementation of TPMT testing. Br J Clin Pharmacol. 2014 Apr;77(4):704-14. doi: 10.1111/bcp.12226.
Other Identifiers
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C04-001
Identifier Type: -
Identifier Source: org_study_id
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