Evaluation of Brain Changes in ALL Patients on Therapy

October 27, 2023 updated by: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Clinical Study of the Therapy Neurotoxicity Using Quantitative Assessment of the Brain Structures and Functions by MRI, EEG and Evoked Potentials in Patients With Acute Lymphoblastic Leukemia Over 6 Years Old

The study is aimed at assessing changes in the brain of patients from 6 to 18 years old with a diagnosis of acute lymphoblastic leukemia during chemotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Children with acute lymphoblastic leukemia receive long-term combined chemotherapy treatment, one of the main part of this treatment is methotrexate. Methotrexate can cause acute, subacute, and long-term neurotoxicity. Clinical symptoms of neurotoxicity, such as seizures, aphasia, are often associated with leukoencephalopathy. However, leukoencephalopathy may develop asymptomatically in children receiving methotrexate.

The effect of chemotherapy on the neurological status of patients is widely covered in the literature. There are very few studies devoted to the quantitative assessment of MRI parameters, especially in children. MRI is a non-invasive method that does not harm the patient and can be used to assess absolutely all structures of the brain.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 117997
        • Recruiting
        • Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology
        • Contact:
          • Dmitry Balashov, MD, PhD
          • Phone Number: 6534 +7(495)287-6570
          • Email: bala8@yandex.ru
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. patients from 6 to 18 years old
  2. diagnosis of acute lymphoblastic leukemia during chemotherapy

Exclusion Criteria:

  1. patients less then 6, and older then 18 years old
  2. patients who cannot perform the study MRI without general anesthesia
  3. Refusal to sign informed consent.
  4. The presence of absolute contraindications to MRI studies.
  5. Extremely serious condition of the patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Time Frame: Before the start of therapy
macromolecular proton fraction (MPF) in brain tissue.
Before the start of therapy
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Time Frame: 36 ± 3 days after the start of the therapy..
macromolecular proton fraction (MPF) in brain tissue.
36 ± 3 days after the start of the therapy..
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Time Frame: ap to 1 week After completing three courses of consolidation chemotherapy.
macromolecular proton fraction (MPF) in brain tissue.
ap to 1 week After completing three courses of consolidation chemotherapy.
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Time Frame: ap to 1 week After confirmation of remission status, optionally provided.
macromolecular proton fraction (MPF) in brain tissue.
ap to 1 week After confirmation of remission status, optionally provided.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
T1 maping
Time Frame: Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
T1 mapping (ms) is a magnetic resonance imaging technique used to calculate at 4 time points
Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
apparent diffusion coefficient
Time Frame: Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
value of apparent diffusion coefficient in mm2/s calculated at 4 time points
Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
percentage of the water myelin fraction
Time Frame: Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
water myelin fraction calculated at 4 time points
Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
value of the cerebral blood flow
Time Frame: Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
cerebral blood flow (CBF) (ml/100g/min) in brain tissue. calculated at 4 time points
Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 21, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCPHOI-2019-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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