Akademik Veri Yönetim Sistemi
Yağcı A. M. (Yürütücü)
Diğer Ülkelerdeki Özel Organizasyonlar Tarafından Desteklenmiş Proje, 2024 - 2029
This is an open label, multicenter, randomized phase 3 study to compare event-free survival of odronextamab monotherapy (arm 1) versus SOC (arm 2; salvage therapy followed by autologous stem cell transplant [ASCT]) for participants with relapsed/refractory (R/R) aggressive B-NHL.Participants in arm 1 will receive 4 cycles (21-days per cycle) of inductiontreatment administered intravenously (IV) with step-up dosing in cycle 1 (C1) to mitigate risk of cytokine release syndrome (CRS). Cycle 1 consists of an initial dose of 0.7 mg (split as 0.2 mg on cycle 1 day 1 [C1D1] and 0.5 mg onC1D2), an intermediate dose-1 of 4 mg (split as 2 mg on C1D8 and 2 mg on C1D9), followed by intermediate dose-2 of 20 mg (split as 10 mg on C1D15 and 10 mg on C1D16). From cycle 2 up to cycle 4, odronextamab is This is an open label, multicenter, randomized phase 3 study to compare event-free survival of odronextamab monotherapy (arm 1) versus SOC (arm 2; salvage therapy followed by autologous stem cell transplant [ASCT]) for participants with relapsed/refractory (R/R) aggressive B-NHL. Participants in arm 1 will receive 4 cycles (21-days per cycle) of induction treatment administered intravenously (IV) with step-up dosing in cycle 1 (C1) to mitigate risk of cytokine release syndrome (CRS). Cycle 1 consists of an initial dose of 0.7 mg (split as 0.2 mg on cycle 1 day 1 [C1D1] and 0.5 mg on
C1D2), an intermediate dose-1 of 4 mg (split as 2 mg on C1D8 and 2 mg on C1D9), followed by intermediate dose-2 of 20 mg (split as 10 mg on C1D15 and 10 mg on C1D16). From cycle 2 up to cycle 4, odronextamab is administered intravenously at the recommended phase 2 dose (RP2D) of 160 mg on cycle D1, D8, and D15. Participants without progressive disease during induction will continue to maintenance treatment with odronextamab 320 mg every 2 weeks (Q2W) until1 year from start of treatment or progressive disease or death due to any cause, whichever occurs first. Participants in arm 2 (SOC) will receive up to 3 cycles of salvage therapy (ifosfamide, carboplatin, etoposide ± rituximab [ICE ± R], or dexamethasone, cisplatin, cytarabine ± rituximab [DHAP ± R], or gemcitabine, dexamethasone, cisplatin ± rituximab [GDP ± R]) and continue with ASCT following a complete response (CR)/partial response (PR). For participants with chemotherapy toxicity or sub-optimal response, a switch between the pre-defined salvage regimens is allowed and will not be counted as an event. Participants with no optimal response following salvage therapy or at any time during ASCT treatment period, participants may cross over to receive odronextamab treatment for 1 year per arm 1 (Section 6.3.3), and this will be recorded as an event in arm 2 prior to crossover. Participants (arm 1 and 2) who complete the treatment period or discontinue treatment earlier will be followed for clinical follow-up (monthly at 30, 60, and 90 days and efficacy assessments every 12 weeks [Q12W] through year 2 and every 24 weeks [Q24W] thereafter) until disease progression or completion of the follow-up period.