Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy

Acute Leukemia Clinical Trial

Official title:

Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy at Cipto Mangunkusumo Hospital and Its Affecting Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279900
• Other study ID #: IndonesiaUI
• Status: Completed
• Start date: October 2, 2017
• Est. completion date: July 16, 2018

Study information

• Verified date: September 2018
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 16, 2018
• Est. primary completion date: May 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusomo hospital	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	october 2017
Secondary	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).	November 2017