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

Phase 1

Conditions: Primary centra nervous system lymphoma
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-005015-16-FI

Lead Sponsor: Oulu University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 44

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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 Outcome Measures

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