Status:
COMPLETED
Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma
Lead Sponsor:
Pfizer
Collaborating Sponsors:
UCB Pharma
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 therapi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2013
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00868608
Start Date
July 30 2009
End Date
June 27 2013
Last Update
October 31 2017
Active Locations (42)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294-3300
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3330
3
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
4
Loma Linda University Cancer Center
Loma Linda, California, United States, 92350 1700