Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)



Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/15/2018
Start Date:January 2015
End Date:November 2019

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A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination With Ibrutinib Compared to Ibrutinib Alone, in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

This study evaluates the addition of ublituximab, a novel monoclonal antibody, to ibrutinib
compared to ibrutinib alone in previously treated Chronic Lymphocytic Leukemia (CLL) patients
with high-risk cytogenetic features. Half of the participants will receive ublituximab in
combination with ibrutinib, while the other half will receive ibrutinib alone.


Inclusion Criteria:

- Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment

- At least one high-risk cytogenetic feature defined by the presence of 17p deletion,
11q deletion and/or p53 mutation

- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

- Any major surgery, chemotherapy or immunotherapy within the last 21 days

- Evidence of hepatitis B virus, hepatitis C virus or known HIV infection

- Autologous hematologic stem cell transplant within 3 months of study entry. Prior
Allogeneic hematologic stem cell transplant is excluded

- Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's
transformation)

- Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's
tyrosine kinase (BTK)
We found this trial at
121
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Baltimore, Maryland 21215
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Baltimore, Maryland 21215
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Blacksburg, Virginia 24060
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Boca Raton, Florida 33486
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Boston, Massachusetts 02111
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Camp Hill, Pennsylvania 17011
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Charlotte, North Carolina 28204
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Clearwater, Florida 33761
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Durham, North Carolina 27710
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East Brunswick, New Jersey 08816
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Fayetteville, Arkansas 72703
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Fullerton, California 92835
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Hermitage, Tennessee 37076
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