Acute LeukemiaNCT03279900
Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy
An observational study of Acute Leukemia, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Acute Leukemia
- How many people
- 101 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Oct 2017to 16 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Medical record of Acute Limphoblastic Leukemia patients at Cipto Mangunkusumo Hospital, in period of 2012 - 2014
Who may be able to join
None listed.
Who cannot join
- Incomplete medical record data.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusomo hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy at Cipto Mangunkusumo Hospital and Its Affecting Factors
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.
- Conditions
- Acute Leukemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: November 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start2 Oct 2017
- Primary completion16 May 2018
- Study completion16 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dewi Selvina Rosdiana, Universitas Indonesia
- Investigators
- Rianto Setiabudy, Professor, Study director, Departemen of Pharmacology and therapeutics, FMUI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279900
- Sponsor's protocol ID
- IndonesiaUI
- Status last verified
- Sep 2018
- First submitted
- 28 Aug 2017
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy at Cipto Mangunkusumo Hospital and Its Affecting Factors
- ClinicalTrials.gov ID
- NCT03279900
- Acronym / sponsor ID
- IndonesiaUI
- Conditions
- Acute Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Medical record of Acute Limphoblastic Leukemia patients at Cipto Mangunkusumo Hospital, in period of 2012 - 2014
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Incomplete medical record data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
The relationship of the incidence of hematotoxicity with influencing factors
Time frame: November 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rianto Setiabudy, Professor study director
Departemen of Pharmacology and therapeutics, FMUI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of hematotoxicity in acute limphoblastic leukemia children during maintenance phase therapy. (time frame: october 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.