Non Hodgkin Lymphoma Clinical Trial
Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma
Summary
The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.
Eligibility Criteria
Inclusion Criteria:
Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.
Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.
Measurable disease with adequate bone marrow function, renal and hepatic function
Exclusion Criteria:
History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
Prior allogeneic hematopoietic stem cell transplant (HSCT).
Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.
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There are 33 Locations for this study
Birmingham Alabama, 35294, United States
Birmingham Alabama, 35294, United States
Birmingham Alabama, 35294, United States
Loma Linda California, 92350, United States
Loma Linda California, 92354, United States
Loma Linda California, 92354, United States
Mission Hills California, 91345, United States
Mission Hills California, 91345, United States
Chicago Illinois, 60612, United States
Saint Louis Park Minnesota, 55426, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
Hackensack New Jersey, 07601, United States
Hawthorne New York, 10532, United States
Allentown Pennsylvania, 18103, United States
Carlisle Pennsylvania, 17015, United States
Hershey Pennsylvania, 17033, United States
Lewistown Pennsylvania, 17044, United States
Philadelphia Pennsylvania, 19111, United States
State College Pennsylvania, 16803, United States
Houston Texas, 77030, United States
Gent , 9000, Belgium
Leuven , 3000, Belgium
Wilrijk , 2610, Belgium
Berlin , 10117, Germany
Berlin , 13353, Germany
Shatin, N.T. , , Hong Kong
Debrecen , 4012, Hungary
Kaposvar , 7400, Hungary
Kashiwa Chiba, 277-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Aichi , 460-0, Japan
Aichi , 466-8, Japan
Fukuoka , 811-1, Japan
Fukuoka , , Japan
Kanagawa , 259-1, Japan
Tokyo , 135-8, Japan
Seoul Korea, 135-7, Korea, Republic of
Rotterdam , 3015 , Netherlands
Rotterdam , 3015 , Netherlands
Singapore , 169 6, Singapore
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