Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma



Status:Active, not recruiting
Conditions:Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:August 2012
End Date:December 2019

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An Open Label Phase I/II Study of the Efficacy and Safety of Ublituximab in Patients With B-cell Non-Hodgkin Lymphoma Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy

The purpose of this study is to determine whether ublituximab is safe and effective in
patients with relapsed or refractory B-cell lymphoma who were previously treated with
rituximab.


Inclusion Criteria:

- Relapsed or Refractory B-cell Lymphoma

- Measurable or Evaluable Disease

- Previously treated with at least one line of rituximab or a rituximab based therapy

- Patients ineligible for high dose or combination chemotherapy + stem cell transplant

- ECOG Performance Status of 0, 1 or 2

- No active or chronic infection of Hepatitis B or C and no history of HIV based on
negative serology

Exclusion Criteria:

- Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study
entry

- Prior autologous or allogeneic stem cell transplantation within 3 months of study
entry

- History of severe hypersensitivity or anaphylaxis to prior rituximab

- Uncontrolled inter-current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, brain metastasis, or psychiatric illness that would limit compliance with
study requirements

- Pregnant women
We found this trial at
8
sites
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Athens, GA
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Bethesda, MD
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Huntsville, Alabama 35805
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from
Huntsville, AL
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Jonesboro, Arkansas 72401
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from
Jonesboro, AR
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from
Macon, GA
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from
Memphis, TN
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Morristown, New Jersey 07962
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from
Morristown, NJ
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New York, NY
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