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NCT04770922 Clinical Trial

Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia

Adverse Drug Event Clinical Trial

Official title:
Pharmacogenomic Analysis of 6-mercaptopurine in Pediatric Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04770922
Other study ID # C04-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 23, 2021
Est. completion date November 10, 2021

Study information
Verified date February 2023
Source Cipherome, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.

Description:

The study objective is to clinically validate that the presence of recently discovered novel genetic variation adversely affects a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients using biobank samples.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date November 10, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility Inclusion Criteria: - Pediatric acute lymphoblastic leukemia (ALL) subjects - 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: - Pediatric ALL subjects who did NOT receive 6-mercaptopurine - No biobank sample - No WBC level

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Stanford University Stanford California

Sponsors (2)
Lead Sponsor Collaborator
Cipherome, Inc. Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Lennard L. Implementation of TPMT testing. Br J Clin Pharmacol. 2014 Apr;77(4):704-14. doi: 10.1111/bcp.12226. — View Citation

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. — View Citation

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 methyltransfer — View Citation

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 lymphoblast — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Novel genetic variants impact on 6-mercaptopurine adverse drug reactions Objective is to clinically validate the presence of novel genetic variants and its impact on adverse drug reactions in a population of pediatric ALL patients treated with 6-MP 1 year
Secondary Evaluating relationship of genetic variants to ancestry A secondary objective of this study is to compare the impact of the novel genetic variants with other known genetic variants contributing to ADR risk. 1 year
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