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: 14.1Level: 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-ES
- Lead Sponsor
- MedImmune, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 187
? 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
? 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 Outcome Measures
Name Time Method