Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia

November 19, 2018 updated by: Dewi Selvina Rosdiana, Indonesia University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jakarta
      • Jakarta Pusat, Jakarta, Indonesia, 10430
        • Cipto Mangunkusomo hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
August 2017 - May 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
July 2017 - May 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Study Director: Rianto Setiabudy, Professor, Department of Pharmacology and therapeutic, FMUI
  • Study Chair: Djajadiman Gatot, Professor, Department of Pediatric

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2017

Primary Completion (Actual)

October 15, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

August 17, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (Actual)

August 21, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaFKUI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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