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OpenTrials
Completed

NCT Number: NCT03255668

Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia

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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cipto Mangunkusomo hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia, the relationship the event with genotyping and phenotyping

    Time frame: 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 outcomes

  1. other Factors that can influence the incidence of hematotoxicity

    Time frame: July 2017 - May 2018

    relaps risk stratification (High risk or standard risk), nutrition status,and albumin levels

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2017
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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