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CompletedNCT03279900Updated Sep 19, 2018

Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy

An observational study in Acute Leukemia, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2018-09-19.

Sponsored by Indonesia University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
101
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
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

Eligibility 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.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
101 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. The Incidence of hematotoxicity in acute limphoblastic leukemia children during maintenance phase therapy.

    based on medical record data: Incidence of anemia, Neutropenia, and thrombocytopenia in acute limphoblastic leukemia children during maintenance phase therapy.

    Time frame: october 2017

Secondary outcomes

  1. The relationship of the incidence of hematotoxicity with influencing factors

    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).

    Time frame: November 2017

06

Study locations

1 site
  • Cipto Mangunkusomo hospital
    Jakarta Pusat, Jakarta 10430, Indonesia
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03279900
Lead sponsor
Indonesia University
Responsible party
Dewi Selvina Rosdiana (Researcher at Department of Pharmacology and Therapeutics Faculty of Medicine University of Indonesia, Indonesia University) — Principal investigator
First posted
Sep 12, 2017
Start date
Oct 2, 2017
Primary completion
May 16, 2018
Completion
Jul 16, 2018
Last update
Sep 19, 2018

Study contacts

Rianto Setiabudy, Professor
study director · Departemen of Pharmacology and therapeutics, FMUI

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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