A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
- Conditions
- Relapsed or refractory diffuse large B-cell lymphoma(DLBCL)MedDRA version: 17.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002565-38-PL
- Lead Sponsor
- MedImmune, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
• Histologically confirmed aggressive B-cell DLBCL, including FL transforming to DLBCL & Grade III FL
• Willing to provide some or all of archived DLBCL tumor sample if a sufficient sample quantity is available. If no archived sampleis available or no marrow involvement is present, an optional additional biopsy may be requested.
• Relapsed from or refractory to at least one treatment chemioterphy regimen containing rituximab
• Eligible for ASCT
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Life expectancy of = 12 weeks
• Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from screening, and must agree to continue using such precautions after the final dose of investigational product for at least 180 days
• 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 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
• Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment
• Previous MAb or other treatment specifically directed against CD19
• Prior autologous or allogeneic SCT
• New York Heart Association = Class II congestive heart failure;
• History of other invasive malignancy within 5 years except for localized/in situ, carcinomas.
• Evidence of active infection, unless clinically stable per the investigator's evaluation
• Any inflammatory or immune-related disease that is not well-controlled on stable doses of medication for at least 10 days.
• Active hepatitis B as defined by seropositivity for hepatitis B surface antigen (HBsAG). Subjects with positive hepatitis B core antibody titers and normal liver transaminases are allowed provided that antiviral prophylaxixs is administered per institutional guidelines. Subjects with hepatitis C antibody will be eligible provided that they do not have elevated liver transaminases or other evidence of active hepatitis
• 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 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 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
- Secondary Outcome Measures
Name Time Method