ALL, ChildhoodALLNCT04593745
Intraocular Pressure in Children With Acute Lymphoblastic Leukemia (ALL) Treated With High Dose Steroids
A study testing Intraocular pressure measurment in people with ALL, Childhood and Steroid-Induced Glaucoma, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Childhood ALL patients are treated with high dose steroids. The study will follow the intraocular pressure of children treated in according to an AIEOP-BFM protocol, during the induction phase that will be compared to the pressure before treatment. Read more about this study
- Who is it for?
- Ages 1 month to 20 years
- Conditions the study is for
- ALL, Childhood, Steroid-Induced Glaucoma
- What is being tested?
- Intraocular pressure measurment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Jul 2018to Jul 2024
- Phase
- Interventional
- 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 month to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ALL diagnosis
- treated with an AIEOP-BFM protocol (including steroids)
Who cannot join
- Any prior eye condition that can affect intra ocular pressure or its measurement
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider Children's Medical Center of Israel
Petah Tikva
Naomi Litichever, PhD, 972-3-9253669
About this study
Official title: Intraocular Pressure in Children With ALL Treated With High Dose Steroids
Childhood ALL patients are treated with high dose steroids. The study will follow the intraocular pressure of children treated in according to an AIEOP-BFM protocol, during the induction phase that will be compared to the pressure before treatment. Potential risk factors for developing elevated intraocular pressure will be estimated.
Read the detailed description
Children with ALL in Israel are treating according to the BFM ALL Protocol which contains high dose steroid therapy. One of the known side effects of high dose steroids is Intraocular hypertension, glaucoma, and even irreversible optic nerve injury. Early diagnosis of elevated intraocular pressure (IOP) and early therapeutic interventions might help to prevent future ocular damage.
The purpose of this study is to determine the risk of developing evaluate Intraocular pressure during high dose steroid therapy. If elevated IOP will be common enough, we will try to corelate the risk of elevated IOP with potential risk factors, such as initial IOP, WBC at diagnosis, etc.
Intraocular pressure will be measured by ophthalmologists using iCare devise: TONOPEN during general anesthesia at the day of diagnosis of ALL before steroid therapy initiation, and then after 15 and 33 days. Children with elevated IOP will continue ophthalmologists' follow up and treatment as necessary.
All parents or patients' guardians will sign informed consent for participating in the study.
The study group contains all newly diagnosed children with ALL in Schneider Children Medical Center.
- Conditions
- ALL, Childhood, Steroid-Induced Glaucoma
- Being tested
- Intraocular pressure measurment
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular pressure measurmentDevice
Intraocular pressure measurmentt using iCare devise: TONOPEN
| Study group | Role | What they receive |
|---|---|---|
| ALL AIEOP-BFM induction | Other | Intraocular pressure messured in children treated with steroids Receives: Device: Intraocular pressure measurment |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-ocular pressure (IOP)
Elevated IOP will be defined as pressure >21 mmHg; The risk of developing elevated IOP will be correlated with potential risk factors (T ALL vs. B ALL; WBC at diagnosis; initial IOP at diagnosis etc.)
Measured: 15 days of steroid treatment
intra-ocular pressure (IOP)
Elevated IOP will be defined as pressure >21 mmHg; The risk of developing elevated IOP will be correlated with potential risk factors (T ALL vs. B ALL; WBC at diagnosis; initial IOP at diagnosis etc.)
Measured: 1 month of steroid treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start9 Jul 2018
- Primary completionJun 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALL, ChildhoodStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shlomi Barzilai Birenboim, Principal investigator, Schneider Children's Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593745
- Sponsor's protocol ID
- 0262-18-RMC
- Acronym
- ALL
- Status last verified
- Oct 2021
- First submitted
- 5 Apr 2020
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: upon request
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure in Children With ALL Treated With High Dose Steroids
- ClinicalTrials.gov ID
- NCT04593745
- Acronym / sponsor ID
- ALL / 0262-18-RMC
- Conditions
- ALL, Childhood, Steroid-Induced Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 20 Oct 2020 (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.
Childhood ALL patients are treated with high dose steroids. The study will follow the intraocular pressure of children treated in according to an AIEOP-BFM protocol, during the induction phase that will be compared to the pressure before treatment. Potential risk factors for developing elevated intraocular pressure will be estimated.
Detailed description
Children with ALL in Israel are treating according to the BFM ALL Protocol which contains high dose steroid therapy. One of the known side effects of high dose steroids is Intraocular hypertension, glaucoma, and even irreversible optic nerve injury. Early diagnosis of elevated intraocular pressure (IOP) and early therapeutic interventions might help to prevent future ocular damage.
The purpose of this study is to determine the risk of developing evaluate Intraocular pressure during high dose steroid therapy. If elevated IOP will be common enough, we will try to corelate the risk of elevated IOP with potential risk factors, such as initial IOP, WBC at diagnosis, etc.
Intraocular pressure will be measured by ophthalmologists using iCare devise: TONOPEN during general anesthesia at the day of diagnosis of ALL before steroid therapy initiation, and then after 15 and 33 days. Children with elevated IOP will continue ophthalmologists' follow up and treatment as necessary.
All parents or patients' guardians will sign informed consent for participating in the study.
The study group contains all newly diagnosed children with ALL in Schneider Children Medical Center.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALL AIEOP-BFM induction | Other | Device: Intraocular pressure measurmentIntraocular pressure messured in children treated with steroids |
Who may qualify
- Ages
- 1 month to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ALL diagnosis
- treated with an AIEOP-BFM protocol (including steroids)
Key exclusion criteria (1 listed)
- Any prior eye condition that can affect intra ocular pressure or its measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular pressure measurmentIntraocular pressure measurmentt using iCare devise: TONOPEN | Device | ALL AIEOP-BFM induction |
Primary outcome
intra-ocular pressure (IOP)
Time frame: 15 days of steroid treatment
Elevated IOP will be defined as pressure >21 mmHg; The risk of developing elevated IOP will be correlated with potential risk factors (T ALL vs. B ALL; WBC at diagnosis; initial IOP at diagnosis etc.)
intra-ocular pressure (IOP)
Time frame: 1 month of steroid treatment
Elevated IOP will be defined as pressure >21 mmHg; The risk of developing elevated IOP will be correlated with potential risk factors (T ALL vs. B ALL; WBC at diagnosis; initial IOP at diagnosis etc.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No. upon request
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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.
Shlomi Barzilai Birenboim principal investigator
Schneider Children's Medical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular pressure measurment in people with ALL, Childhood and Steroid-Induced Glaucoma, run by Rabin Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Oct 2021. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shlomit Barzilai Birenboim, MD (03-9253461, Bshlomit@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intra-ocular pressure (IOP) (time frame: 15 days of steroid treatment). The study lists 2 primary outcomes in all. 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 22 Oct 2021.