At a glance
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20150288 A Phase 2 Open-label Study Investigating the Safety and Efficacy of Blinatumomab After Frontline R-Chemotherapy in Adult Subjects With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma (DLBCL)
In Brief
A Phase 2 clinical trial evaluating Blinatumomab, Investigator's Choice Chemotherapy, and 1 other intervention for High-risk Diffuse Large B-Cell Lymphoma. Completed, enrolled 47 participants across 24 sites in 6 countries.
Detailed Summary
A phase 2, multicenter, open-label, single arm clinical trial in adults with newly diagnosed aggressive high-risk DLBCL.
Study Details
Timeline
Interventions
Blinatumomab monotherapy was supplied in single-use sterile glass injection vials and administered as an IV infusion.
During the run-in period participants received 6 cycles of standard of care rituximab-chemotherapy dosed per investigator's institution standard as follows: * R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine,prednisone) * R-DA-EPOCH (rituximab and dose adjusted-etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) or * R-CHOEP (rituximab and cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide).
Dexamethasone 20 mg IV: within 1 hour prior to start of treatment in each treatment cycle, and within 1 hour prior to dose-step (increase).