Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia

Completed

• Conditions: Leukemia, Lymphoblastic; Mercaptopurine Adverse Reaction

• Registration Number: NCT03255668
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-07-25
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-21
• Primary Completion: 2018-10-15
• Status Verified: 2018-11
• Study Completion: 2018-11-01
• Last Update Submitted: 2018-11-19
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Acute lymphoblastic leukemia (ALL) patients, 1 until 18 years old, male or female, who come to Cipto Mangunkusumo Hospital, Jakarta, Indonesia
• Received 6MP chemotherapy at least 1 month maintenance phase
• Received maintenance phase treatment regimen
• Willing to participate in research, signed informed consent and obtained parental consent to participate in research

Exclusion Criteria

• Patients are experiencing severe infections
• Patients receiving colony stimulating factor (CSF), allopurinol, mesalazine, olsalazine, and sulfasalazine

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia, the relationship the event with genotyping and phenotyping	August 2017 - May 2018	Haematology data (hemoglobin, leukocites, platelets, absolute neutrophil count), TPMT genotyping, and blood concentration of 6-meMP and 6-TGN (=phenotyping).

Secondary Outcome Measures

Name	Time	Method
other Factors that can influence the incidence of hematotoxicity	July 2017 - May 2018	relaps risk stratification (High risk or standard risk), nutrition status,and albumin levels

Trial Locations

Locations (1)

Cipto Mangunkusomo hospital; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia