A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Completed · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia (CLL)

In brief

The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.

Key facts

Study ID

NCT01466153

Run by

MedImmune LLC

People needed

183

Starts

2012-02-07

Expected to finish

2016-01-08

Last updated by the study team

2017-05-31

Who can join

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

You may qualify if…

• Histologically confirmed B-cell Chronic Lymphocytic Leukemia (CLL) according to the National Cancer Institute criteria; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; 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;
• Exposure to bendamustine within the 180 days before study enrollment
• Prior autologous or allogeneic stem cell transplantation (SCT);
• Clinically significant abnormality on electrocardiogram (ECG) as determined by the treating physician or medical monitor;
• History of other invasive malignancy within 5 years except for localized/in situ carcinomas;
• Evidence of active infection, Confirmed current central nervous system involvement by leukemia or lymphoma;

Where it is running

• Research Site — Burbank, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Palm Springs, California, United States
• Research Site — Skokie, Illinois, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Fargo, North Dakota, United States
• Research Site — Dayton, Ohio, United States
• Research Site — Newark, Ohio, United States
• Research Site — Watertown, South Dakota, United States
• Research Site — Lubbock, Texas, United States
• Research Site — Morgantown, West Virginia, United States
• Research Site — Antwerp, Belgium
• Research Site — Arlon, Belgium
• Research Site — Kortrijk, Belgium
• Research Site — Mons, Belgium
• Research Site — Wilrijk, Belgium
• Research Site — Yvoir, Belgium
• Research Site — Toronto, Ontario, Canada
• Research Site — Greenfield Park, Quebec, Canada
• Research Site — Montreal, Quebec, Canada
• Research Site — Amiens, France
• Research Site — Bayonne, France
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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