An observational study in Mercaptopurine Adverse Reaction and Leukemia, Lymphoblastic, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2018-11-20.
Sponsored by Indonesia University · Observational
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.
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.
Exclusion Criteria:
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).
Time frame: August 2017 - May 2018
other Factors that can influence the incidence of hematotoxicity
relaps risk stratification (High risk or standard risk), nutrition status,and albumin levels
Time frame: July 2017 - May 2018
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Indonesia University