A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

• Drug: Inotuzumab ozogamicin
  
  1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles
  Other Name: CMC-544
• Drug: Rituximab
  
  375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles
• Drug: rituximab + gemcitabine
  
  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
• Drug: rituximab +bendamustine
  
  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

• Experimental: 1
  
  Inotuzumab ozogamicin+rituximab
  Interventions:
  

  • Drug: Inotuzumab ozogamicin
  • Drug: Rituximab
• Active Comparator: 2
  
  Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine
  Interventions:
  

  • Drug: rituximab + gemcitabine
  • Drug: rituximab +bendamustine

Inclusion Criteria:

• relapsed/refractory/persistent CD20+/CD22+ aggressive NHL (DLBCL, transformed indolent lymphoma with DLBCL, primary mediastinal large B-cell lymphomas)
• up to 3 prior regimens containing cytotoxic chemotherapies
• not candidates for intensive high-dose chemotherapy, with or without an autologous stem cell transplant

Exclusion Criteria:

• Any prior allogeneic hematopoietic stem cell transplant; autotransplant within prior 4 months
• anti-CD22 treatment or radioimmunotherapy within prior 6 months
• contraindication to both investigator choice regimens
• chronic liver disease, history of veno-occlusive disease