Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy

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.

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Key information

Conditions

Acute Leukemia

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cipto Mangunkusomo hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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 outcomes

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).

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Sep 12, 2017
Registry last updated: Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed