Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Eudract: 2008-007645-31 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universitätsklinikum Köln | OTHER |
| Ludwig-Maximilians - University of Munich | OTHER |
| University Hospital Heidelberg | OTHER |
| University Hospital Ulm |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether combined chemotherapy [rituximab plus high dosage methotrexate, lomustine, and procarbazine] followed by maintenance therapy with procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL] in patients > 65 years.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | 3g/m² i.v. max. 9 times | ||
| Lomustine | Drug | 110 mg/m² p.o., max. 3 times | ||
| Procarbazine | Drug | 60 mg/m² p.o. for 10 days, max. 3 times 100 mg p.o. for 5 days, max. 6 times | ||
| Rituximab | Drug | 375 mg/m² i.v., max. 10 times |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate | 30 days after end of immuno-chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response | within 5 years | |
| Overall survival time | within 5 years | |
| Neuropsychological state (according to Mini-Mental State and IPCG testing) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerald Illerhaus, PD Dr. | Contact | +497612703785 | Gerald.Illerhaus@uniklinik-freiburg.de | |
| Elvira Burger | Contact | +497612707378 | elvira.burger@uniklinik-freiburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Gerald Illerhaus, PD Dr. | University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology | Recruiting | Freiburg im Breisgau | 79106 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18953065 | Background | Illerhaus G, Marks R, Muller F, Ihorst G, Feuerhake F, Deckert M, Ostertag C, Finke J. High-dose methotrexate combined with procarbazine and CCNU for primary CNS lymphoma in the elderly: results of a prospective pilot and phase II study. Ann Oncol. 2009 Feb;20(2):319-25. doi: 10.1093/annonc/mdn628. Epub 2008 Oct 26. | |
| 27843136 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| within 5 years |
| (Serious) adverse events ([S]AEs) | within 30 days after treatment |
| Fritsch K, Kasenda B, Schorb E, Hau P, Bloehdorn J, Mohle R, Low S, Binder M, Atta J, Keller U, Wolf HH, Krause SW, Hess G, Naumann R, Sasse S, Hirt C, Lamprecht M, Martens U, Morgner A, Panse J, Frickhofen N, Roth A, Hader C, Deckert M, Fricker H, Ihorst G, Finke J, Illerhaus G. High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study). Leukemia. 2017 Apr;31(4):846-852. doi: 10.1038/leu.2016.334. Epub 2016 Nov 15. |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D008130 | Lomustine |
| D011344 | Procarbazine |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D001549 | Benzamides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| 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 |
Not provided
Not provided