NCT04767152

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

4.9 years

First QC Date

February 16, 2021

Last Update Submit

October 27, 2023

Conditions

Acute Leukemia

Keywords

Quantitative MRIacute lymphoblastic leukemianeurotoxitychildren

Outcome Measures

Primary Outcomes (4)

  • percentage of the macromolecular proton fraction (MPF) in brain tissue.

    macromolecular proton fraction (MPF) in brain tissue.

    Before the start of therapy

  • percentage of the macromolecular proton fraction (MPF) in brain tissue.

    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.

    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.

    macromolecular proton fraction (MPF) in brain tissue.

    ap to 1 week After confirmation of remission status, optionally provided.

Secondary Outcomes (4)

  • T1 maping

    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

    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

    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

    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

Interventions

MRIDIAGNOSTIC_TEST

The quantitative assessment of MRI parameters, The macromolecular proton fraction (MPF) (%) in brain tissue. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. After completing three courses of consolidation chemotherapy. Point 4. After confirmation of remission status, optionally provided.

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients from 6 to 18 years old
  • diagnosis of acute lymphoblastic leukemia during chemotherapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology

Moscow, 117997, Russia

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Nataliia f Kriventsova

CONTACT

+7 (495)2876570nataliya.krivencova@fccho-moscow.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 23, 2021

Study Start

February 16, 2021

Primary Completion

January 1, 2026

Study Completion

January 21, 2026

Last Updated

October 30, 2023

Record last verified: 2023-10

Locations

RU(1)