drugset
drugset / Trial / NCT01453205

A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

NCT01453205 ↗

Phase 2 Completed 187 enrolled MedImmune LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.

Timeline

Start
2012-02-27
Primary completion
2016-07-11
Completion
2016-07-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Inebilizumab Monoclonal antibody 2 mg/kg Intravenous
Subject Inebilizumab Monoclonal antibody 4 mg/kg Intravenous
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule — Intravenous
Background Carboplatin Small molecule — Intravenous
Background Cisplatin Other / unclassified 100 mg/m2 Intravenous
Background Cytarabine Small molecule 2 g Intravenous
Background Dexamethasone Small molecule 40 mg Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous
Background Ifosfamide Small molecule 5 g Intravenous

Indications

diffuse large B-cell lymphoma