A Phase 2 Randomized Open-label Study of MEDI-551 in AdultsWith Relapsed or Refractory DLBC
- 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-IT
- Lead Sponsor
- MEDIMMUNE ONCOLOGY INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
• 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: 0
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 Main Objective: Determine if MEDI-551, when used in combination with salvage<br>chemotherapy, Ifosafamide-carboplatin-etoposide (ICE) or<br>Dexamethasone-cytarabine (DHAP) in patients with relapsed or<br>refractory DLBCL who are eligible for Autologous Stem Cell Tansplant<br>(ASCT), has superior efficacy compared to rituximab in the same<br>population.;Secondary Objective: Evaluate anti-tumor activities and overall survival (OS),to determine an<br>acceptable dose for MEDI-551 when used in combination with ICE or<br>DHAP, to describe the safety and tolerability, to determine the<br>immunogenicity (IM), and to describe the pharmacokinetic (PK) profile.;Primary end point(s): The overall response rate (ORR), including Partial Response (PR) and<br>Complete Response (CR), of subjects treated with MEDI-551 when used<br>in combination with ICE or DHAP versus rituximab in combination with<br>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