Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia

Completed

• Conditions: Acute Lymphoblastic Leukemia, Pediatric; Adverse Drug Event

• Registration Number: NCT04770922
• Lead Sponsor: Cipherome, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-22
• Study Start: 2021-02-23
• Study First Posted: 2021-02-25
• Primary Completion: 2021-08-30
• Study Completion: 2021-11-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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Exclusion Criteria

• Pediatric ALL subjects who did NOT receive 6-mercaptopurine
• No biobank sample
• No WBC level

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Novel genetic variants impact on 6-mercaptopurine adverse drug reactions	1 year	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

Secondary Outcome Measures

Name	Time	Method
Evaluating relationship of genetic variants to ancestry	1 year	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States