Status:
COMPLETED
A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Lead Sponsor:
MedImmune LLC
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 27 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2016
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT01453205
Start Date
February 27 2012
End Date
July 11 2016
Last Update
March 12 2018
Active Locations (81)
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1
Research Site
Birmingham, Alabama, United States, 35061
2
Research Site
Burbank, California, United States, 91501
3
Research Site
Palm Springs, California, United States, 92262
4
Research Site
Sylmar, California, United States, 91342