Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia

Leukemia, Lymphoblastic Clinical Trial

Official title:

Haematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia: Focus on Genotyping and Phenotyping of Mercaptopurine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255668
• Other study ID #: IndonesiaFKUI
• Status: Completed
• Start date: July 25, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: November 2018
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 1, 2018
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoblastic
• Leukemia, Lymphoid
• Mercaptopurine Adverse Reaction
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusomo hospital	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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