Prima-CNS

The primary objective of this study is to investigate if intensified chemotherapy followed by consolidating high-dose chemotherapy and autologous stem-cell transplantation (HDTASCT) is superior to conventional chemotherapy with R-MP followed by maintenance in elderly patients with newly diagnosed PCNSL regarding 1-year progression free survival (PFS). Secondary objectives are the investigation of quality of life, remission after treatment, event free survival, overall survival (OS) and treatment related morbidities (neurotoxicity and adverse events).

{ "short_title": "Prima-CNS", "data_mode": "910", "data_mode_number": "000000059", "official_title": null, "accrual_state": "running", "therapeutic_value": "not_applicable", "therapieansatz_value": "not_applicable", "therapieintervention_value": "not_applicable", "therapielinie_value": "first", "ctgov_number": null, "eudract_number": " 2024-512320-11-00", "general_contact_email": "sal-aml-register@ukdd.de", "general_contact_phone": "+49 351-45818380", "hauptpruefer_dd_name": null, "description_laie_de": "Das Hauptziel dieser Studie besteht darin, zu untersuchen, ob eine intensivierte Chemotherapie in Kombination von Hochdosis-Chemotherapie und autologer Stammzelltransplantation (HDT ASCT) gegen\u00fcber einer konventionellen Chemotherapie mit R-MP und anschlie\u00dfender Erhaltungstherapie bei \u00e4lteren Patienten mit neu diagnostiziertem PCNSL hinsichtlich des progressionsfreien 1-Jahres-\u00dcberlebens \u00fcberlegen ist. Sekund\u00e4re Ziele sind die Untersuchung der Lebensqualit\u00e4t, der Remission nach der Behandlung, \r\nEreignisfreies \u00dcberleben, Gesamt\u00fcberleben (OS) und behandlungsbedingte Morbidit\u00e4ten (Neurotoxizit\u00e4t und \r\nunerw\u00fcnschte Ereignisse).", "description_laie_en": "The primary objective of this study is to investigate if intensified chemotherapy followed by consolidating high-dose chemotherapy and autologous stem-cell transplantation (HDT\u0002ASCT) is superior to conventional chemotherapy with R-MP followed by maintenance in \r\nelderly patients with newly diagnosed PCNSL regarding 1-year progression free survival (PFS). Secondary objectives are the investigation of quality of life, remission after treatment, event free survival, overall survival (OS) and treatment related morbidities (neurotoxicity and \r\nadverse events).", "description_expert_de": "Das Hauptziel dieser Studie besteht darin, zu untersuchen, ob eine intensivierte Chemotherapie in Kombination von Hochdosis-Chemotherapie und autologer Stammzelltransplantation (HDT ASCT) gegen\u00fcber einer konventionellen Chemotherapie mit R-MP und anschlie\u00dfender Erhaltungstherapie bei \u00e4lteren Patienten mit neu diagnostiziertem PCNSL hinsichtlich des progressionsfreien 1-Jahres-\u00dcberlebens \u00fcberlegen ist. Sekund\u00e4re Ziele sind die Untersuchung der Lebensqualit\u00e4t, der Remission nach der Behandlung, \r\nEreignisfreies \u00dcberleben, Gesamt\u00fcberleben (OS) und behandlungsbedingte Morbidit\u00e4ten (Neurotoxizit\u00e4t und \r\nunerw\u00fcnschte Ereignisse).", "description_expert_en": "The primary objective of this study is to investigate if intensified chemotherapy followed by consolidating high-dose chemotherapy and autologous stem-cell transplantation (HDT\u0002ASCT) is superior to conventional chemotherapy with R-MP followed by maintenance in \r\nelderly patients with newly diagnosed PCNSL regarding 1-year progression free survival (PFS). Secondary objectives are the investigation of quality of life, remission after treatment, event free survival, overall survival (OS) and treatment related morbidities (neurotoxicity and \r\nadverse events).", "rechtsgrundlage_value": null, "phase_amg_value": null, "main_cat_id": 4, "sub_cat_id": 24 }