Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia

Cipherome

Status: Completed

Conditions: Adverse Drug Event; Acute Lymphoblastic Leukemia, Pediatric

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04770922

C04-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Pediatric ALL patients on 6-mercaptopurine

Description:

Pediatric ALL patients treated with 6-mercaptopurine who did not experience neutropenia.

Pediatric ALL patients on 6-mercaptopurine with neutropenia

Description:

Pediatric ALL patients treated with 6-mercaptopurine who experienced neutropenia.