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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 170

Inclusion Criteria

• Histologically confirmed aggressive B-cell DLBCL, including FL transforming to DLBCL & Grade III FL
• Relapsed from or refractory to at least one treatment containing rituximab or another anti-CD20 based immunotherapy combined with anthracycline- or anthracenedione-based chemotherapy
• Eligible for ASCT
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Life expectancy of = 12 weeks
• Adequate hematological function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

• Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment
• Previous cancer therapy for DLBCL other than anthracycline- or anthracenedione based chemoimmunotherapy, monotherapy rituximab prior to first line therapy and/or as a maintenance therapy, or limited field radiotherapy
• Prior autologous or allogeneic SCT
• New York Heart Association = Class II congestive heart failure;
• Clinically significant abnormality on ECG
• History of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ.
• Evidence of active infection
• Documented current central nervous system involvement by leukemia or lymphoma

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Evaluate anti-tumor activities and overall survival (OS),to determine an acceptable dose for MEDI-551 when used in combination with ICE or DHAP, to describe the safety and tolerability, to determine the immunogenicity (IM), and to describe the pharmacokinetic (PK) profile.;Primary end point(s): The overall response rate (ORR), including Partial Response (PR) and Complete Response (CR), of subjects treated with MEDI-551 when used in combination with ICE or DHAP versus rituximab in combination with ICE or DHAP in subjects with relapsed or refractory DLBCL.;Timepoint(s) of evaluation of this end point: Day 1080;Main Objective: Determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosafamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Sem Cell Tansplant (ASCT), has superior efficacy compared to rituximab in the same population.<br>

Secondary Outcome Measures

Name	Time	Method

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