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| Name | Class |
|---|---|
| Institute of Hematology & Blood Diseases Hospital, China | OTHER |
| Qianfoshan Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Children's Hospital of Hebei Province |
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The purpose of this study was to assess the efficacy and safety of individualized treatment of 6-mercaptopurine (6-MP) in Chinese children with acute lymphoblastic leukemia, and to investigate the dose-concentration-response (DER) relationship between thiopurine metabolites and adverse events. The individualized administration of 6-MP was established in Chinese children with acute lymphoblastic leukemia.
To inflict minimal pain on the child contributing blood samples, opportunistic sampling design was chosen to collect pharmacokinetic samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment regimen | Active Comparator | 6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015. |
|
| Individualized treatment regimen | Experimental | 6-mercaptopurine was administered on the basis of Chinese Children Cancer Group (CCCG) protocol-ALL 2015 combined with Clinical Pharmacogenetics Implementation Consortium (CPIC), genotypes and the concentrations of 6-TGN in red blood cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6-mercaptopurine | Drug | 6-mercaptopurine was administered orally to patients once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| leukopenia | Leukopenia was graded by common toxicity criteria as follows: Grade 3, 1.0-2.0 × 109/L, and Grade 4, < 1.0 × 109/L. | 6 weeks |
| thiopurine-induced leukopenia | Resolution of leukopenia was determined after 6-MP dose reduction or discontinuation, both in the absence of other apparent causes for the leukopenia or its disappearance. | 6-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| hepatotoxicity | Hepatotoxicity was defined as aspartate aminotransferase (AST) or alanine transaminase (ALT) levels 2-fold above the upper limit without cytolysis. | 6 weeks |
| 6-thioguanine nucleotides (6-TGN) concentrations in erythrocytes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhao, Ph.D | Contact | 86053188383308 | zhao4wei2@hotmail.com | |
| Yan H Shi, Ph.D | Contact | 86053188383308 | zhao4wei2@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Zhao, Ph.D | Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Key Laboratory of Experimental Haematology, Department of Paediatric Haematology, Institute of Haematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Tanjin | Tianjin Municipality | 300020 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37753808 | Derived | Zhou Y, Wang L, Sun LR, Zhang L, Wang HM, Liu XT, Yang F, Wu KL, Liang YL, Zhao BB, Zhuang Y, Fu JQ, Song C, Li Y, Wang LZ, Xu HJ, Gu Y, van den Anker J, Ju XL, Zhu XF, Zhao W. Individualized Use of 6-Mercaptopurine in Chinese Children with ALL: A Multicenter Randomized Controlled Trial. Clin Pharmacol Ther. 2024 Feb;115(2):213-220. doi: 10.1002/cpt.3061. Epub 2023 Oct 16. |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015122 | Mercaptopurine |
| ID | Term |
|---|---|
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011687 | Purines |
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| OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
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| Standard treatment | Procedure | The initial dose is 50mg/m2. The dose was adjusted according to white blood cells. |
|
| Individualized treatment | Procedure | The initial dose is determined according to the genotypes of patients combined with Clinical Pharmacogenetics Implementation Consortium (CPIC). The dose was adjusted according to white blood cells, genotypes and the concentrations of 6-TGN in red blood cells. |
|
Peripheral blood samples were obtained from steady-state plasma concentrates by opportunistic sampling design.
| 3 months |
| 6-methylmercaptopurine nucleotides (6-MMPN) concentrations in erythrocytes. | Peripheral blood samples were obtained from steady-state plasma concentrates by opportunistic sampling design. | 3 months |
| China |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |