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NCT Number: NCT04770922

Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia, Pediatric Adverse Drug Event Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Stanford, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Novel genetic variants impact on 6-mercaptopurine adverse drug reactions

    Time frame: 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 outcomes

  1. Evaluating relationship of genetic variants to ancestry

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cipherome, Inc.

Industry

Collaborators

  • Stanford University

Registry information

Official study title

Pharmacogenomic Analysis of 6-mercaptopurine in Pediatric Acute Lymphoblastic Leukemia

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2021
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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