Study identifier:CD-ON-MEDI-551-1019
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL
Chronic Lymphocytic Leukemia (CLL)
Phase 2
No
MEDI-551, Rituximab, Bendamustine
All
183
Interventional
18 Years - 99 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Mar 2016 by MedImmune, LLC
MedImmune, LLC
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: MEDI-551 (dose level 1) + Bendamistine | Drug: MEDI-551 MEDI-551 will be administered by Intravenous (IV) infusion. There will an initial cycle and up to 5 subsequent cycles. Drug: Bendamustine Bendamustine will be administered to subjects in each treatment group at 70 mg/m2 by IV infusion on Days 1 and 2 of each 28-day cycle (30-min infusion). |
Experimental: MEDI-551 (dose level 2) + Bendamustine | Drug: MEDI-551 MEDI-551 will be administered by Intravenous (IV) infusion. There will an initial cycle and up to 5 subsequent cycles. Drug: Bendamustine Bendamustine will be administered to subjects in each treatment group at 70 mg/m2 by IV infusion on Days 1 and 2 of each 28-day cycle (30-min infusion). |
Active Comparator: Rituximab + Bendamustine | Drug: Rituximab Rituximab will be administered at 375 mg/m2 by IV infusion on Day 2 of Cycle 1 and then at 500 mg/m2 on Day 1 of up to 5 subsequent 28-day cycles (90-minute infusion). Other Name: Rituxan; MabThera Drug: Bendamustine Bendamustine will be administered to subjects in each treatment group at 70 mg/m2 by IV infusion on Days 1 and 2 of each 28-day cycle (30-min infusion). |