Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy

Completed

• Conditions: Acute Leukemia

• Registration Number: NCT03279900
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-12
• Study Start: 2017-10-02
• Primary Completion: 2018-05-16
• Study Completion: 2018-07-16
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Incidence of hematotoxicity in acute limphoblastic leukemia children during maintenance phase therapy.	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

Name	Time	Method
The relationship of the incidence of hematotoxicity with influencing factors	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).

Trial Locations

Locations (1)

Cipto Mangunkusomo hospital; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia