A Phase 2 Randomized Open-label Study of MEDI-551 in Adults With Relapsed or Refractory DLBC

MedImmune, LLC0 个研究点目标入组 180 人开始时间: 2012年9月18日最近更新: 2016年8月22日

试验速览

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•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

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