1. Event-free survival (EFS) (Time Frame - up to 24 months after end of treatment): time from randomization to premature end of treatment due to any reason, lymphoma progression or death, whichever occurs first
Secondary outcome:
1. Overall survival (OS) (Time Frame - up to 24 months after end of treatment): time from randomization to death of any course
2. Progression free survival (PFS) (Time Frame - up to 24 months after end of treatment): time from randomization until disease progression, relapse or death from any cause
3. Remission rate prior to consolidation therapy (Time Frame - assesed at RA II (Arm B: day 18-20 of cycle 2, each cycle is 21 days. Arm A: day 18-20 of cycle 4, each cycle is 21 days)): Remission prior to consolidation therapy will be determined at RA II and will be divided in CR, uCR, PR, CD, PD according to IPCG criteria
4. Remission rate after consolidation therapy (Time Frame - 30 days after ASCT): Remission after consolidation therapy will be determined on day 30 after ASCT and will be divided in CR, uCR, PR, SD, PD according to IPCG criteria
5. rate of patients reaching consolidation therapy (Time Frame - determined up to 4 weeks after response assessment II): defined as obtaining at least the first dose of consolidation therapy, will be determined after the response assessment II (following 4 cycles of MATRix in the control arm and following 1 cycle of R/HD-MTX and 2 cycles of MATRix in the experimental arm)
6. Quality of life (QOL), EORTC QLQ-C30, (Time Frame - up to 24 months after end of treatment): EORTC (European Organization for research and cancer treatment) QLQ-C30, measured during screening, at response assessment II, and with beginning of RA III every 12 months until end of follow-up
7. Quality of life (QOL), QLQ-BN20 (Time Frame - up to 24 months after end of treatment): EORTC (European Organization for research and cancer treatment) QLQ-BN20; measured during screening, at response assessment II, and with beginning of RA III every 12 months until end of follow-up
Active Comparator: Control treatment (Arm A) Patients receive four courses of MATRix (Rituximab 2 x 375 mg/m2, HD-Methotrexate 3.5 g/m2, HD-Cytarabine 2 x 2 g/m2, Thiotepa 30 mg/m2; i.v.) as induction treatment. Response assessment with gadolinium-enhanced brain MRI (centrally reviewed) takes place after course two and four. Patient with at least PR proceed to 3rd course of MATRix after first response assessment and to HCT-ASCT (BCNU 400 mg/m2, Thiotepa 4 x 5 mg/kg; i.v.) after second response assessment. Collection of autologous stem cells is planed after the second course of MATRix.
Experimental: Experimental treatment (Arm B) As induction treatment, patients receive one course of Rituximab/HD-Methotrexate (Rituximab 375 mg/m2, HD-Methotrexate 3.5 g/m2; i.v.). In the absence of clinical signs of progression, patients proceed to two courses of MATRix (Rituximab 2 x 375 mg/m2, HD-Methotrexate 3.5 g/m2, HD-Cytarabine 2 x 2 g/m2, Thiotepa 30 mg/m2; i.v.) followed by a response assessment with gadolinium-enhanced brain MRI (centrally reviewed). Patients with at least PR will proceed to HCT-ASCT (BCNU 400 mg/m2, thiotepa 4 x 5 mg/kg; i.v.). Collection of autologous stem cells is planed after the first course of MATRix
Experimental Treatment: one course Rituximab/HD-Methotrexate, two courses of MATRix: De-escalated induction treatment with R/HD-MTX and two courses of MATRix
Control intervention: four courses of MATRix: Patients receive four courses of MATRix as induction treatment.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"OptiMATe: De-escalated Induction Treatment in Primary CNS Lymphoma"
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