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| Name | Class |
|---|---|
| Stanford University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric ALL patients on 6-mercaptopurine | Pediatric ALL patients treated with 6-mercaptopurine who did not experience neutropenia. | ||
| Pediatric ALL patients on 6-mercaptopurine with neutropenia | Pediatric ALL patients treated with 6-mercaptopurine who experienced neutropenia. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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The study population are pediatric patients, under 21 years of age, diagnosed with acute lymphoblastic leukemia patients between April 20, 2012 to August 6, 2020, and received 6-mercaptopurine for therapeutic purposes. All patients were recruited by the investigators at Stanford University Lucile Packard Children's Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Sakamoto, MD, PhD | Stanford University | Principal Investigator |
| Stephanie M Smith, MD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26181173 | Background | 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. | |
| 31244663 |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Observational study of previously collected biobank specimens
| Background |
| 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. |
| 21270794 | Result | 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. |
| 25624441 | Result | 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. |
| 23962279 | Result | Lennard L. Implementation of TPMT testing. Br J Clin Pharmacol. 2014 Apr;77(4):704-14. doi: 10.1111/bcp.12226. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D064419 | Chemically-Induced Disorders |