Overview
Sponsor-declared trial summary
Acute lymphoblastic leukemia and lymphoma
Investigate/estimate brain fluid clearance (BFC) at the individual level in children aged 12-17 years undergoing clinically indicated intrathecal chemotherapy (methotrexate, and where applicable cytarabine) for blood or lymph cancer.
Key facts
- Sponsor
- Oslo University Hospital HF
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-07-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Pharmacokinetic
Investigate/estimate brain fluid clearance (BFC) at the individual level in children aged 12-17 years undergoing clinically indicated intrathecal chemotherapy (methotrexate, and where applicable cytarabine) for blood or lymph cancer.
Secondary objectives 3
- Evaluate safety/tolerability and explore the association between brain fluid clearance and Day 0-7 solicited AEs/AESIs.
- Explore association between brain fluid clearance and fatigue at 3 months.
- Explore association between brain fluid clearance and cognitive function at 3 months and 2 years after intrathecal chemotherapy.
Conditions and MedDRA coding
Acute lymphoblastic leukemia and lymphoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age. Participant must be in the age range 12 to 17 years at the time of signing the informed consent.
- Type of Participant and Disease Characteristics. Individuals undergoing intrathecal chemotherapy with MTX for blood or lymph cancer and being treated at Oslo University Hospital.
- Weight. Body weight is above 50 kg.
- Sex and Contraceptive/Barrier Requirements. Both male and female. WOCBP may be included only if they meet protocol pregnancy-testing requirements, have a confirmed menstrual period, have a negative highly sensitive urine or serum pregnancy test before inclusion/intervention, and use highly effective contraception where applicable from inclusion through Day 7 safety follow-up. WOCBP means a post-menarche female participant who is not permanently sterile and not post-menopausal.
- Informed Consent. Documented informed consent/assent must be obtained before any study-specific procedure. Ages 12-15: consent from person(s) with parental responsibility plus age-adapted information and assent/participation according to maturity. Ages 16-17: participant informed consent plus consent from person(s) with parental responsibility. If a participant reaches 18 years before further protocol-defined procedures, express adult informed consent must be obtained.
Exclusion criteria 4
- Medical condition. Renal failure
- Medical condition. Hypersensitivity/Allergy to contrast agents
- Medical condition. Lowered seizure threshold
- Other. Pregnancy or breast feeding.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Exploratory model-derived BFC indices [absorption half-life (t½abs), time to maximal blood concentration (Tmax) of gadobutrol and maximum concentration (Cmax)] from the predefined gadobutrol popPK model using actual dose and sampling times.
Secondary endpoints 3
- Solicited AEs/AESIs Day 0-7, including headache, nausea, dizziness and other predefined symptoms; SAE/SUSAR occurrence; 30-minute post-dose observation findings.
- Mental Fatigue Scale score at 3 months.
- Change in neuropsychological test/questionnaire measures from baseline to 3 months and 2 years.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Gadobutrol 1.0 mmol/mL solution for injection
PRD10809539 · Product
- Active substance
- Gadobutrol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRATHECAL USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08CA09 — GADOBUTROL
- Marketing authorisation
- PL 00221/0400
- MA holder
- GE HEALTHCARE LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital HF
- Sponsor organisation
- Oslo University Hospital HF
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Per Kristian Eide
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Per Kristian Eide
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Authorised, recruitment pending | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_EU CT 2025-522453-20-00_For publication | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment _EU CT 2025-522453-20-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_EU CT 2025-522453-20-00_Barn 12-15 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC EU CT 2025-522453-20-00 | 1 |
| Synopsis of the protocol (for publication) | D1_NO_Synopsis_EU CT 2025-522453-20-00 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-13 | Norway | Acceptable 2026-06-29
|
2026-07-03 |