The principal objective of the study is to investigate tolerability of highdosechemotherapy and autologous stem cell transplant in elderly patientsolder than 65 years with newly-diagnosed or relapsed primary lymphomasof the central nervous system.

Phase 1

• Conditions: Primary central nervous system lymphoma (PCNSL) is an aggressiveNon-Hodgkin Lymphoma (NHL) mostly of B-cell origin, which exclusivelyinvades the central nervous system compartment. It accounts for 3% to4% of all primary brain tumours and 4% to 6% of extra-nodallymphomas. The incidence of PCNSL in immunocompetent patients hasbeen steadily increasing over the last 30 years. Patients older than 60years account for more than 50% of all PCNSL cases.; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-001628-72-DE
• Lead Sponsor: Medical Center - University of Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-07
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1. Immunocompetent patients with newly-diagnosed primary central nervous system B-cell lymphoma.
2. Age > 65 years not eligible for treatment within the MATRix/IELSG43 trial.
3. Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist.
4. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
5. Disease exclusively located in the CNS.
6. At least one measurable lesion.
7. ECOG-Performance Status = 2.
8. Patients eligible for intensive treatment according to physician´s choice.
9. Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is temporarily legally not competent due to his or her disease.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 51

Exclusion Criteria

1. Congenital or acquired immunodeficiency.
2. Systemic lymphoma manifestation (outside the CNS).
3. Isolated ocular lymphoma without manifestation in the brain parenchyma or spinal cord.
4. Previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other kinds of cancer without evidence of disease for at least 5 years.
5. Previous systemic Non-Hodgkin lymphoma at any time.
6. Inadequate renal function (creatinine clearance <60 ml/min).
7. Inadequate hepatic, cardiac or pulmonary function according to physician`s decision.
8. Active hepatitis B or C disease.
9. HIV infection, previous organ transplantation or other clinical evident form of immunodeficiency.
10. Concurrent treatment with other experimental drugs or participation in a clinical trial within the last thirty days before the start of this study.
11. Third space fluid accumulation >500 ml.
12. Hypersensitivity to study treatment or any component of the formulation.
13. Taking any medications likely to cause interactions with the study medication.
14. Known or persistent abuse of medication, drugs or alcohol.
15. Patient without legal capacity and who is unable to understand the nature, significance and consequences of the study and without designated legal representative.
16. Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator.
17. Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to investigate the efficacy of age-adapted induction treatment followed by high-dose chemotherapy and autologous stem cell transplantation regarding 1-year PFS in elderly and fit patients with primary CNS lymphoma.;Secondary Objective: Secondary objectives are the investigation of OS, treatment response (rate of complete responses on day 30 after HDT-ASCT) and treatment related morbidities (neurotoxicity and adverse advents).;Primary end point(s): Primary endpoint: progression free survival (PFS) at 1 year;Timepoint(s) of evaluation of this end point: Time from start of treatment until disease progression or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Key secondary endpoint(s):<br>•Rate of complete responses (CR) <br>•Progression-free survival (PFS) <br>•Overall survival (OS) <br>•Rate of neurotoxicity <br>•Non relapse mortality (NRM)<br>•(Serious) adverse events ([S]AEs)<br>•Toxicity<br>;Timepoint(s) of evaluation of this end point: CR: on day +30 after HDT-ASCT<br>PFS: as time from start of treatment until progression, relapse or death from any cause, whatever happens first<br>OS: as time from start of treatment until death from any cause<br>Rate of Neurotoxocity: on day + 30 after HDT-ASCT and continuously thereafter<br>Non relapse mortality (NRM): coutinously<br>SAEs: from the first administration of the study medication until day 30 after HDT-ASCT<br>Toxicity: continously