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Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy

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ClinicalTrials.gov Identifier: NCT03279900
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Dewi Selvina Rosdiana, Indonesia University

Brief Summary:
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.

Condition or disease
Acute Leukemia

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy at Cipto Mangunkusumo Hospital and Its Affecting Factors
Actual Study Start Date : October 2, 2017
Actual Primary Completion Date : May 16, 2018
Actual Study Completion Date : July 16, 2018





Primary Outcome Measures :
  1. The Incidence of hematotoxicity in acute limphoblastic leukemia children during maintenance phase therapy. [ Time Frame: october 2017 ]
    based on medical record data: Incidence of anemia, Neutropenia, and thrombocytopenia in acute limphoblastic leukemia children during maintenance phase therapy.


Secondary Outcome Measures :
  1. The relationship of the incidence of hematotoxicity with influencing factors [ Time Frame: November 2017 ]
    The relationship of the incidence of hematotoxicity (anemia, Neutropenia, thrombocitopenia) with ALL stratification (High risk or Standard risk, as written in the medical record), nutritional status (normal or malnutrition), and albumin levels (normal or Hypoalbuminemia). The determination of nutritional status is based on body weight (Kg) and Height (Meters). Determination of nutritional status using cutoff Z score based on The growth chart of WHO 2006 for children 0-5 years, and ideal weight percentage according to Waterlow criteria for children above 5 years (recommendation of Indonesian Pediatric Association).



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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
Medical record of Acute Limphoblastic Leukemia patients at Cipto Mangunkusumo Hospital, in period of 2012 - 2014
Criteria

Medical record of Acute Limphoblastic Leukemia patients at Cipto Mangunkusumo Hospital, in period of 2012 - 2014, with 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.

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): NCT03279900


Locations
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Indonesia
Cipto Mangunkusomo hospital
Jakarta Pusat, Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
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Study Director: Rianto Setiabudy, Professor Departemen of Pharmacology and therapeutics, FMUI

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Responsible Party: Dewi Selvina Rosdiana, Researcher at Department of Pharmacology and Therapeutics Faculty of Medicine University of Indonesia, Indonesia University
ClinicalTrials.gov Identifier: NCT03279900     History of Changes
Other Study ID Numbers: IndonesiaUI
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases