C83.3
Conditions
Interventions
Group 1: Induction treatment:
2 cycles (every 3 weeks), stem-cell harvest after first cycle:
- Rituximab 375 mg/m² i.v. (d-0,4)
- MTX 3,5 g/m² i.v. (d1)
- AraC 2x2 g/m²/d i.v. (d2-3)
Consolidation:
Sponsors
Albert-Ludwigs-Universität Freiburg Medizinische Fakultät, Dekanat
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: Key inclusion criteria: 1. Immunocompetent patients with newly-diagnosed or relapsed primary central nervous system B-cell lymphoma 2. Age > = 65 years as well as patients between 65 and 70 years years old, that are not eligible for treatment within the MATRix/IELSG43 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, liquor or cranial nerves 6. At least one measurable lesion 7. Cumulative Illness Rating Scale-Geriatric (CIRS-G) <6 8. ECOG-Performance Status = 2 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
Exclusion criteria
Exclusion criteria: Key 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 bone marrow (platelet count decreased =CTC grade 1, anemia =CTC grade 1, neutrophil count decreased =CTC grade 1), renal (creatinine clearance 500 ml 13.Hypersensitivity to study treatment or any component of the formulation 14.Taking any medications likely to cause interactions with the study medication 15.Known or persistent abuse of medication, drugs or alcohol 16.Patient without legal capacity and who is unable to understand the nature, significance and consequences of the study and without designated legal representative 17.Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator 18.Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of feasibility of the study procedures. Progression-free survival (PFS) as time from start of treatment until progression, relapse or death from any cause, whatever happens first | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoint(s): •Recruitment rate •Rate of complete responses (CR) on day +30 after HDT-ASCT •Progression-free survival (PFS) from start of treatment until progression, relapse or death from any cause •Overall survival (OS) as time from start of treatment until death from any cause. •Rate of neurotoxicity on day + 30 after HDT-ASCT and continuously thereafter | — |
Countries
Germany
Contacts
Public ContactElisabeth Schorb
Universitätsklinikum FreiburgMedizinische Klinik IHämatologie, Onkologie und Stammzelltransplantation
Outcome results
None listed