A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Completed · Phase 2

Conditions studied: Diffuse Large B-Cell Lymphoma

In brief

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 with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.

Key facts

Study ID

NCT01453205

Run by

MedImmune LLC

People needed

187

Starts

2012-02-27

Expected to finish

2016-07-11

Last updated by the study team

2018-03-12

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Burbank, California, United States
• Research Site — Palm Springs, California, United States
• Research Site — Sylmar, California, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Westwood, Kansas, United States
• Research Site — Hazard, Kentucky, United States
• Research Site — Lafayette, Louisiana, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — The Bronx, New York, United States
• Research Site — Fargo, North Dakota, United States
• Research Site — Dayton, Ohio, United States
• Research Site — Newark, Ohio, United States
• Research Site — Sylvania, Ohio, United States
• Research Site — Hershey, Pennsylvania, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Charleston, South Carolina, United States
• Research Site — Knoxville, Tennessee, United States
• Research Site — Dallas, Texas, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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