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| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
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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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | first diagnosis of PCNSL: combined chemotherapy with methotrexate |
|
| B | Experimental | Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methotrexate | Drug | 8000mg/m2 i.v., max. 2 cycles |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | 30 days after blood stem cell transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response | within 5 years | |
| Overall survival time | within 5 years | |
| Neuropsychological state according to Mini-Mental State |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerald Illerhaus, Dr. | Contact | 00497612703785 | Gerald.Illerhaus@uniklinik-freiburg.de | |
| Andreas Zähringer, Dr. | Contact | 00497612707370 | andreas.zaehringer@uniklinik-freiburg.de |
| Name | Affiliation | Role |
|---|---|---|
| JĂĽrgen Finke, Prof. Dr. | University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Freiburg | Recruiting | Freiburg im Breisgau | 79106 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16864853 | Background | Illerhaus G, Marks R, Ihorst G, Guttenberger R, Ostertag C, Derigs G, Frickhofen N, Feuerhake F, Volk B, Finke J. High-dose chemotherapy with autologous stem-cell transplantation and hyperfractionated radiotherapy as first-line treatment of primary CNS lymphoma. J Clin Oncol. 2006 Aug 20;24(24):3865-70. doi: 10.1200/JCO.2006.06.2117. Epub 2006 Jul 24. | |
| 28559537 |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D000069283 | Rituximab |
| D003561 | Cytarabine |
| D013852 | Thiotepa |
| D002330 | Carmustine |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Rituximab | Drug | 375mg/m2, max. 8 times |
|
| Cytarabine | Drug | 3000mg/m2 die i.v., 2 days (max. 2 cycles) |
|
|
| Thiotepa | Drug | 40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days |
|
| Carmustin | Drug | 400mg/m2 i.v. for 1 day |
|
|
| 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 |
| Kasenda B, Ihorst G, Schroers R, Korfel A, Schmidt-Wolf I, Egerer G, von Baumgarten L, Roth A, Bloehdorn J, Mohle R, Binder M, Keller U, Lamprecht M, Pfreundschuh M, Valk E, Fricker H, Schorb E, Fritsch K, Finke J, Illerhaus G. High-dose chemotherapy with autologous haematopoietic stem cell support for relapsed or refractory primary CNS lymphoma: a prospective multicentre trial by the German Cooperative PCNSL study group. Leukemia. 2017 Dec;31(12):2623-2629. doi: 10.1038/leu.2017.170. Epub 2017 May 31. |
| 27476790 | Derived | Illerhaus G, Kasenda B, Ihorst G, Egerer G, Lamprecht M, Keller U, Wolf HH, Hirt C, Stilgenbauer S, Binder M, Hau P, Edinger M, Frickhofen N, Bentz M, Mohle R, Roth A, Pfreundschuh M, von Baumgarten L, Deckert M, Hader C, Fricker H, Valk E, Schorb E, Fritsch K, Finke J. High-dose chemotherapy with autologous haemopoietic stem cell transplantation for newly diagnosed primary CNS lymphoma: a prospective, single-arm, phase 2 trial. Lancet Haematol. 2016 Aug;3(8):e388-97. doi: 10.1016/S2352-3026(16)30050-3. Epub 2016 Jul 13. |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |