Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia

NCT ID: NCT03255668

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-25
• Study Completion Date: 2018-11-01

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.

Conditions

Mercaptopurine Adverse Reaction; Leukemia, Lymphoblastic

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Dewi Selvina Rosdiana

Medical Doctor, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rianto Setiabudy, Professor

Role: STUDY_DIRECTOR

Department of Pharmacology and therapeutic, FMUI

Djajadiman Gatot, Professor

Role: STUDY_CHAIR

Department of Pediatric

Locations

Cipto Mangunkusomo hospital

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

IndonesiaFKUI

Identifier Type: -

Identifier Source: org_study_id