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



Status:Completed
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:February 2012
End Date:January 2016

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A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL

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


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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;
We found this trial at
15
sites
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Detroit, MI
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Antwerpen,
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Fargo, ND
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Lubbock, TX
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Morgantown, WV
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Newark, OH
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Palm Springs, CA
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Shreveport, LA
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Skokie, IL
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Watertown, SD
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