Blood-brain-barrier disruption therapy in primary central nervous system lymphoma

Chemoimmunotherapy in conjunction with blood-brain-barrier opening in patients with newly diagnosed or relapsed primary central nervous system lymphoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005015-16-FI

Enrollment

Registered

2016-12-22

Start date

2017-01-24

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary centra nervous system lymphoma

Interventions

Product Name: rituximabi Pharmaceutical Form: Solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Product Name: carboplatin Pharmaceutical Form: Solution for infusion Other d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) A Patients has PCNSL, either newly diagnosed or relapsed 2) The disease had DLBCL histology 3) Patients age is 18-70 years 4) The patient has given an informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1) Whole brain irradiation 2) More than one lines of previous chemotherapy 3) Leesion in the deep brain structures 4) Patient is not able to understand or give informed consent 5) Liver failure 6) Bone marrow failure 7) Severe renal failure 8) Any medication that can not be doscontinued during opening and is a contraindication to opening 9) Any other heath related issue that is a contraindication to hydration, anestesia or other mandatory supportive care 10) WHO performance score 2 or more due to othet reasons than PCNSL 11) Other malignancies unless treated curatively

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the safety and efficacy of chemoimmunotherapy on conjunction with bloodbrain barrier disruption in the therapy of PCNSL as measured by number of patients alive at 2 anf 5 years.;Secondary Objective: Response rate. NUmber of patients disease free at 2 and 5 years. Treatment related adverse effects and long term neurological adverse events.;Primary end point(s): Propotion of patients alive at 2 and 5 years;Timepoint(s) of evaluation of this end point: 2 and 5 years	—

Measure

Time frame

Main Objective: To study the safety and efficacy of chemoimmunotherapy on conjunction with bloodbrain barrier disruption in the therapy of PCNSL as measured by number of patients alive at 2 anf 5 years.;Secondary Objective: Response rate. NUmber of patients disease free at 2 and 5 years. Treatment related adverse effects and long term neurological adverse events.;Primary end point(s): Propotion of patients alive at 2 and 5 years;Timepoint(s) of evaluation of this end point: 2 and 5 years

—

Secondary

Measure	Time frame
Secondary end point(s): Response rate Propotrion of patients disease free at 2 and 5 years Treatmen related adverse events Long term kognitive functioning;Timepoint(s) of evaluation of this end point: 1 and 5 years after the start of therapy	—

Countries

Finland

Contacts

Public ContactTrial center

Oulu University Hospital

outi.kuittinen@ppshp.fi35883153032

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026