Primary diffuse large B-cell lymphoma of the central nervous system (PCNSL) is a rare lymphoma affecting only the central nervous system compartment. PCNSL patients are typically 60 years or older and have poor prognoses. Considering the poor prognosis of this patient population, this randomised phase III trial proposal is of great clinical importance to provide patients optimal treatment.
Conditions
Brief summary
Progression free survival
Detailed description
• Overall survival (OS) • Event free survival (EFS; defined as time from randomization to premature end of treatment (EOT) due to any reason, lymphoma progression or death, whichever occurs first) • Remission during and after induction treatment • Remission after maintenance: 6 months after RAII • Quality of life (QoL): EORTC QLQ-C30, EORTC QLQ-BN20; measured during screening period, at RAII and premature EOT visit and thereafter every 12 months during follow-up.
Interventions
DRUGCARMUSTINE
DRUGCYTARABINE
DRUGPROCARBAZINE
DRUGTHIOTEPA
DRUGRITUXIMAB
DRUGBUSULFAN
Sponsors
Medical Center - University Of Freiburg
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| • Overall survival (OS) • Event free survival (EFS; defined as time from randomization to premature end of treatment (EOT) due to any reason, lymphoma progression or death, whichever occurs first) • Remission during and after induction treatment • Remission after maintenance: 6 months after RAII • Quality of life (QoL): EORTC QLQ-C30, EORTC QLQ-BN20; measured during screening period, at RAII and premature EOT visit and thereafter every 12 months during follow-up. | — |
Countries
Austria, Germany
Outcome results
None listed