Conditions: B-Cell Lymphoma
Keywords: Lymphoma NHL
Allocation: NON_RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 119
Healthy volunteers: no

Brief summary:
The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin \[CMC-544\] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.

Detailed description:

Arms:
arm 1: Follicular arm 2: Diffuse Large B-cell Lymphoma arm 3: Refractory Aggressive NHL

Interventions: intervention 1: inotuzumab ozogamicin intervention 2: inotuzumab ozogamicin intervention 3: inotuzumab ozogamicin intervention 4: Rituximab
Intervention descriptions: intervention 1: IV, 1.8 mg/m2, q4w intervention 2: IV, 1.8 mg/m2, q4w intervention 3: IV, 1.8 mg/m2, q4w intervention 4: rituximab 375 mg/m\^2 via IV infusion on Day 1

Protocol document: