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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03255668 |
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Date of registration:
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17/08/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia
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Scientific title:
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Haematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia: Focus on Genotyping and Phenotyping of Mercaptopurine |
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Date of first enrolment:
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July 25, 2017 |
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Target sample size:
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106 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03255668 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Djajadiman Gatot, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Pediatric |
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Name:
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Rianto Setiabudy, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Pharmacology and therapeutic, FMUI |
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Key inclusion & exclusion criteria
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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
Age minimum:
1 Year
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mercaptopurine Adverse Reaction
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Leukemia, Lymphoblastic
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Primary Outcome(s)
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Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia, the relationship the event with genotyping and phenotyping
[Time Frame: August 2017 - May 2018]
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Secondary Outcome(s)
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other Factors that can influence the incidence of hematotoxicity
[Time Frame: July 2017 - May 2018]
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Secondary ID(s)
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IndonesiaFKUI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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