Conditions: Lymphoma, Non-Hodgkin
Keywords: inotuzumab ozogamicin aggressive Non-Hodgkin lymphoma diffuse large b-cell lymphoma relapsed/refractory lymphoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 338
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.

Detailed description:

Arms:
arm 1: Inotuzumab ozogamicin+rituximab arm 2: Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine

Interventions: intervention 1: Inotuzumab ozogamicin intervention 2: Rituximab intervention 3: rituximab + gemcitabine intervention 4: rituximab +bendamustine
Intervention descriptions: intervention 1: 1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles intervention 2: 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles intervention 3: rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 to 6, every 28 days by IV infusion, 3 to 6 cycles; gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles intervention 4: rituximab 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles; bendamustine 120 mg/m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles

Protocol document: