Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03279900

Enrollment

101

Registered

2017-09-12

Start date

2017-10-02

Completion date

2018-07-16

Last updated

2018-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Indonesia

Outcome results