CRC 11036: An Open-label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin Administered in Combination With Rituximab Compared to Defined Investigator’s Choice Therapy in Subjects With Relapsed or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma
- Type of Study
- Cancer (Oncology) - Lymphoma
- Location
- Swedish Cancer Institute
- Short Description
Purpose: 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.
- Status
- Open to Enrollment
- Principal Investigator
- Henry Kaplan, M.D.
- Eligibility Notes
- 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
- No prior allogeneic hematopoietic stem cell transplant; autotransplant within prior 4 months
- No anti-CD22 treatment or radioimmunotherapy within prior 6 months
- No contraindication to both investigator choice regimens
- No chronic liver disease, history of veno-occlusive disease
- More Info Link
- Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
- Phone
- (206) 215-3086
- CancerResearch@swedish.org
