drugset / Trial / NCT02412267

Study of Ofatumomab in Combination With ICE-chemotherapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)

NCT02412267

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the efficacy and safety of ofatumomab in combination with ICE chemotherapy in subjects with relapsed/refractory DLBCL following failure to combination rituximab and anthracycline based chemotherapy. Participants with the option of potentially curative stem cell therapy may proceed to high dose chemotherapy and stem cell rescue. Participants with disease not considered curable with stem cell therapy, ineligible for or decline stem cell therapy may receive up to a maximum of 6 cycles of study drugs.

Timeline

Start
2011-04
Primary completion
2015-12
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ofatumumab Monoclonal antibody 1000 mg Intravenous
Background Carboplatin Small molecule Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous
Background Ifosfamide Small molecule 1667 mg/m2 Intravenous