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: 187

Inclusion Criteria

•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 sample is available or no marrow involvement is present, an optional additional biopsy may be requested
• Relapsed from or refractory to at least one treatment chemotherapy 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

Exclusion Criteria

•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 prophylaxis 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

Secondary Outcome Measures

Name	Time	Method

Related Trials