C83.3
Conditions
Interventions
Group 1: INDUCTION TREATMENT:
4 cycles MATRix (every 3 weeks), stem-cell harvest after 2nd cycle:
- Rituximab 375 mg/m²/d i.v. (d0,5)
- MTX 3.5 g/m² i.v. (d1)
- Ara-C 2 x 2 g/m²/d i.v. (d2-3)
- Thiot
Sponsors
Klinik für Haematologie, Onkologie und Palliativmedizin, Stuttgart Cancer Center / Tumorzentrum Eva Mayr-StihlKlinikum Stuttgart
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA 1. Immunocompetent patients with newly-diagnosed primary central nervous system B-cell lymphoma 2. Age 18-65 years irrespective of ECOG or 66-70 years (with ECOG Performance Status = 2) 3. 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 localized in the CNS, CSF or cranial nerves 6. At least one measurable lesion 7. Previously untreated patients (previous or ongoing steroid treatment admitted) 8. Sexually active patients of childbearing potential who agree to apply adequate contraceptive measures during study participation 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 ADDITIONAL RANDOMIZATION CRITERIA 1. Sufficient stem cell harvest (= 3 x 106 CD34+ cells/kg of body weight) 2. Complete remission, unconfirmed complete remission or partial remission 3. Central pathology results confirming local results 4. Exclusion criterion no. 6 not applicable for re-check for randomization
Exclusion criteria
Exclusion criteria: 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 Non-Hodgkin lymphoma at any time 6. Only applicable for patient inclusion (registration) not applicable for recheck for randomization. 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 19. Concurrent (or planned) pregnancy or lactation 20. Fertile patients refusing to use safe contraceptive methods during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: Progression-free survival (PFS) time from randomization until progression, relapse, or death from any cause. Progression-free survival PFS: Response Assessment III at the end of study treatment (EOT) visit and every imaging diagnostic assessments during follow-up period: during year 1-2: every 3 month from year 3-5: every 6 month or imaging in case of clinical suspicion of disease progression or relapse | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Efficacy: - Complete response (CR) - Response duration - Overall survival (OS) - Quality of life (QOL): EORTC QLQ-C30. CR will be determined on day 60 after randomization. Response duration is defined as time from CR, CRu or PR until relapse or PD. OS is defined as time from randomization until death of any cause. For overall survival (OS), Quality of life (QLQ), (serious)adverse events (S)AEs, toxicity and neurotoxicity timepoints of evaluation are defined as every assessment during follow up period in accordance with the protocol. year 1-2: every 3 month year 3-5: every 6 month. Response duration observation times for patients where the event of interest was not observed, will be censored at the time last seen alive without the respective event. Safety: - (Serious) adverse events - Toxicity - Neurotoxicity (MMSE, EORTC QLQ-BN20, neuropsychological test battery) Test Battery: ECOG Performance Status, Mini-mental Status Examination (MMSE), EORTC QLQ-C30, EORTC QLQ-BN20, Brief Repeatable Battery of Neuropsychological Tesrs | — |
Countries
Denmark, Germany, Italy, Norway, Switzerland
Contacts
Public ContactElisabeth Schorb
Universitaetsklinikum Freiburg Abteilung Innere Medizin I Haematologie, Onkologie und Stammzelltransplantation
Outcome results
None listed