Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Arms (1)

1. type

   EXPERIMENTAL

   label

   Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2

   description

   Inotuzumab ozogamicin, in combination with rituximab, will be administered to patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma prior to an autologous stem cell transplant (aSCT).

   interventionNames

   1. Drug: inotuzumab ozogamicin (CMC-544)
   2. Drug: rituximab

Primary outcomes (1)

1. measure

   Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy

   timeFrame

   Up to 2 years (9 weeks of 3 21-day cycles and every 3 to 6 months during the long-term follow-up period)

   description

   Response criteria based on National Cancer Institute (NCI) International Response Criteria for non-Hodgkin's lymphoma. CR: no detectable clinical \& radiographic evidence of disease/disease-related symptoms; lymph nodes/nodal masses regressed to normal size (less than or equal to \[≤\] 1.5 cm in greatest transverse diameter for nodes greater than \[\>\] 1.5 cm pre-therapy); spleen \& other organs (if enlarged pre-therapy) regressed in size \& spleen not palpable on physical examination; repeat bone marrow infiltrate clear. PR: \> or equal to (≥) 50% decrease in sum of product diameters (SPD) of 6 largest dominant nodes/nodal masses; no increase in size of other nodes, liver, or spleen; splenic \& hepatic nodules regressed by ≥ 50% in SPD; involvement of other organs usually assessable \& no measurable disease present; no new sites of disease. Participants achieving CR, but with persistent morphologic bone marrow involvement or no bone marrow assessment after treatment were partial responders.