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Subjects who are recruited in this study are LLA patient, who are treated for routine control to Cipto Mangunkusumo Hospital, who meet the inclusion criteria and do not meet the exclusion criteria.
On the day of the control patient, (usually the patient is asked for routine control at week 3 on mercaptopurin) routine blood tests are performed. Patients and parents were given an explanation of this study. If patients and parents are willing to take part in the study, they are asked to sign informed consent. Patients who meet the inclusion criteria and do not meet the exclusion criteria, are recorded for demographic data and 5 ml of blood taking. The blood is directly divided into three, 2 mL for hematologic examination and albumin level, 1 mL for genotyping, and 2 mL for examination of drug levels. Routine hematologic examination and albumin levels were performed in the Cipto Mangunkusumo hospital laboratory. For genotypic examination, blood samples were stored at -80C, until they were used for analysis. For examination of the drug levels the blood sample is centrifuged and the erythrocyte preparation is then stored at -80C, until it is used for analysis.
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| Measure | Description | Time Frame |
|---|---|---|
| Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia, the relationship the event with genotyping and phenotyping | Haematology data (hemoglobin, leukocites, platelets, absolute neutrophil count), TPMT genotyping, and blood concentration of 6-meMP and 6-TGN (=phenotyping). | August 2017 - May 2018 |
| Measure | Description | Time Frame |
|---|---|---|
| other Factors that can influence the incidence of hematotoxicity | relaps risk stratification (High risk or standard risk), nutrition status,and albumin levels | July 2017 - May 2018 |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients with LLA who received 6-MP chemotherapy in the maintenance phase, who come to RSCM, and who meets the inclusion criteria and does not meet the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Rianto Setiabudy, Professor | Department of Pharmacology and therapeutic, FMUI | Study Director |
| Djajadiman Gatot, Professor | Department of Pediatric | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusomo hospital | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 12, 2017 | Aug 17, 2017 | Prot_SAP_ICF_000.pdf |
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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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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |