Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy

NCT ID: NCT03279900

Last Updated: 2018-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-02

Study Completion Date

2018-07-16

Brief Summary

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This study use an observational study design from patient medical records to obtain data on patient demographics, nutritional status, 6MP dosing, and albumin levels of LLA child patients.

Detailed Description

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All medical record data of LLA child patient at maintenance phase therapy, who came to Cipto Mangunkusumo Kiara Hospital in period 2014 - 2016. the data that are colected consist of age, gender, disease stratification, nutritional status, the dosage of 6-MP, albumin levels, hemoglobin levels, leukocyite counts, platelet counts, and absolute neutrophil counts.

Conditions

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Acute Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* LLA Patients, male and female, age 1 - \<18 years
* Received chemotherapy maintenance phase based on Indonesian protocol of ALL - 2013

Exclusion Criteria

* Incomplete medical record data.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Dewi Selvina Rosdiana

Researcher at Department of Pharmacology and Therapeutics Faculty of Medicine University of Indonesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rianto Setiabudy, Professor

Role: STUDY_DIRECTOR

Departemen of Pharmacology and therapeutics, FMUI

Locations

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Cipto Mangunkusomo hospital

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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IndonesiaUI

Identifier Type: -

Identifier Source: org_study_id

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