Primary diffuse large B-cell lymphoma (DLBCL) of the central nervous system is a rare disorder confined to the cerebral parenchyma, leptomeninges, eyes or spinal cord. It accounts for 4 to 6% of all Non- Hodgkin's lymphomas and for 3 to 4% of all primary brain tumors. Incidence of PCNSL has increased over the past 30 years, particularly in immunocompetent individuals. With a median survival of 3 months in untreated individuals, prognosis of PCNSL resembles that of systemic high-grade NHL
Conditions
Brief summary
Event-free survival (EFS, defined as time from randomization to premature end of treatment due to any reason, lymphoma progression or death, whichever occurs first).
Detailed description
• Overall survival (OS) • Progression free survival (PFS) • Remission prior to consolidation therapy – RA II • Remission after consolidation – 30 days after ASCT (RA III) • Proportion of patients reaching consolidation • Quality of life (QoL): EORTC QLQ-C30, EORTC QLQ-BN20; measured during screening period, at EOT (30 days after ASCT) and thereafter every 12 months during follow-up.
Interventions
Sponsors
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival (EFS, defined as time from randomization to premature end of treatment due to any reason, lymphoma progression or death, whichever occurs first). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Overall survival (OS) • Progression free survival (PFS) • Remission prior to consolidation therapy – RA II • Remission after consolidation – 30 days after ASCT (RA III) • Proportion of patients reaching consolidation • Quality of life (QoL): EORTC QLQ-C30, EORTC QLQ-BN20; measured during screening period, at EOT (30 days after ASCT) and thereafter every 12 months during follow-up. | — |
Countries
Austria, Germany, Italy
Outcome results
None listed