Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)

• Drug: inotuzumab ozogamicin
  
  IV, 1.8 mg/m2, q4w
  Other Name: CMC-544
• Drug: Rituximab
  
  rituximab 375 mg/m^2 via IV infusion on Day 1

• Experimental: 1
  
  Follicular
  Interventions:
  

  • Drug: inotuzumab ozogamicin
  • Drug: Rituximab
• Experimental: 2
  
  Diffuse Large B-cell Lymphoma
  Interventions:
  

  • Drug: inotuzumab ozogamicin
  • Drug: Rituximab
• Experimental: 3
  
  Refractory Aggressive NHL
  Interventions:
  

  • Drug: inotuzumab ozogamicin
  • Drug: Rituximab

Inclusion Criteria:

• Subjects with CD20 and CD22-positive, follicular or diffuse large B-cell NHL who have not responded or progressed after 1 or 2 prior therapies; or subjects with CD20 and CD22-positive intermediate/aggressive NHL (diffuse large B-cell, mantle cell, transformed follicular or follicular grade 3b NHL) who have not responded or progressed after 1 or more prior therapies and are refractory to a previous rituximab containing therapy.
• Prior therapy must contain at least one course of rituximab therapy, as single agent or in combination.
• Measurable disease.

Exclusion Criteria:

• Subjects who are candidates for other potentially curative therapies.
• Subjects must not have received previous radioimmunotherapy.
• Subjects who have undergone a prior bone marrow transplantation within the last 6 months.