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Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT03255668
Recruitment Status : Completed
First Posted : August 21, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dewi Selvina Rosdiana, 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.

Condition or disease
Mercaptopurine Adverse Reaction Leukemia, Lymphoblastic

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 [Patient Registry]
Actual Enrollment : 106 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Haematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia: Focus on Genotyping and Phenotyping of Mercaptopurine
Actual Study Start Date : July 25, 2017
Actual Primary Completion Date : October 15, 2018
Actual Study Completion Date : November 1, 2018





Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255668


Locations
Indonesia
Cipto Mangunkusomo hospital
Jakarta Pusat, Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
Study Director: Rianto Setiabudy, Professor Department of Pharmacology and therapeutic, FMUI
Study Chair: Djajadiman Gatot, Professor Department of Pediatric
  Study Documents (Full-Text)

Documents provided by Dewi Selvina Rosdiana, Indonesia University:

Responsible Party: Dewi Selvina Rosdiana, Medical Doctor, MSc, Indonesia University
ClinicalTrials.gov Identifier: NCT03255668     History of Changes
Other Study ID Numbers: IndonesiaFKUI
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dewi Selvina Rosdiana, Indonesia University:
Mercaptopurine, acute lymphoblastic leukemia, hematotoxicity

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors