Primary Non Hodgkin Lymphoma of the Central Nervous System
Conditions
Brief summary
The purpose of this study is to determine whether combined chemotherapy \[rituximab plus high dosage methotrexate (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed by high dosage carmustin/thiotepa\] followed by peripheral blood stem cell transplantation is effective in the treatment of cerebral Non Hodgkin lymphoma \[PCNSL\].
Interventions
DRUGmethotrexate
8000mg/m2 i.v., max. 2 cycles
DRUGRituximab
375mg/m2, max. 8 times
DRUGCytarabine
3000mg/m2 die i.v., 2 days (max. 2 cycles)
DRUGThiotepa
40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
DRUGCarmustin
400mg/m2 i.v. for 1 day
Sponsors
University Hospital Tuebingen
University Hospital Freiburg
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* group A: first diagnosis of PCNSL, histologically confirmed * group B: relapse or progression of PCNSL after MTX containing chemotherapy * age 18 - 65 years * not legally incompetent, physically or mentally incapable of giving consent * written signed and dated informed consent of the legal representative and - if possible - of the patient
Exclusion criteria
* manifestations of further lymphoma outside the CNS * sero-positive for HIV * severe pulmonary, cardiac, hepatic, renal impairment * neutrophil count \< 2.000/µl, platelet count \< 100.000/µl * pulmonary disease with IVC \< 55%, DLCO \< 40% * cardiac ejection fraction \< 50%, uncontrolled malign arrhythmia * creatinine \> 1,5 mg% or creatinine-clearance \< 50ml/min * bilirubin \> 2mg/dl * ascites or pleural effusion (\> 500ml) * pregnancy o r lactation * women with childbearing potential without sufficient contraception * participation in another clinical trial within the last 30 days prior to the begin or parallel to this study * known or current drug or alcohol abuse * known hypersensitivity against methotrexate, cytarabine, thiotepa, BCNU rituximab, leukovorin, dexamethasone, neupogen and neulasta.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate | 30 days after blood stem cell transplantation |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response | within 5 years |
| Overall survival time | within 5 years |
| Neuropsychological state according to Mini-Mental State | within 5 years |
| Neuropsychological assessment (digit span, Hopkins verbal Learning Test-Revised, Trials 1-3, Brief Test of Attention, Trial Making Test, Grooved Pegboard, 6. HVLT-R , EORTC L C30 , EORTC BN20) | within 5 years |
| (Serious) adverse events ([S]AEs) | within 30 days after treatment |
Countries
Germany
Contacts
Primary ContactGerald Illerhaus, Dr.
Backup ContactAndreas Zähringer, Dr.
Outcome results
None listed