Authorised Therapeutic exploratory (Phase II) Acute lymphoblastic leukemia and lymphoma

Individualized Intrathecal Chemotherapy Based on Measurement of Brain Fluid Clearance in Pediatric Patients

EU CTIS ID: 2025-522453-20-00

What this study is testing

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.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.

You likely can't join if

  • Medical condition. Renal failure
  • Medical condition. Hypersensitivity/Allergy to contrast agents
  • Medical condition. Lowered seizure threshold
  • Other. Pregnancy or breast feeding.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.