Status:
COMPLETED
Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Pfizer
Collaborating Sponsors:
UCB Pharma
Conditions:
Lymphoma, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cel...
Eligibility Criteria
Inclusion
- CD20/CD22-positive diffuse large B-cell NHL that has relapsed after 1 or 2 prior therapies; one prior therapy must include anthracyclines and one must include rituximab in combination with chemotherapy
- Relapsed/disease progression within 12 months after start of prior therapy and/or secondary International Prognostic Index (sIPI) score greater than 1
- Eligible for autologous stem cell transplant (aSCT)
Exclusion
- Prior allogeneic hematopoietic stem cell transplant
- Within 6 months prior to test article: autologous transplant, treatment with anti-CD22 antibodies, radio-immunotherapy
- Veno-occlusive disease or sinusoidal obstruction syndrome, chronic liver disease, systemic vasculitides, current or chronic hepatitis B or C infection
Key Trial Info
Start Date :
June 8 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2012
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00867087
Start Date
June 8 2009
End Date
October 31 2012
Last Update
December 5 2017
Active Locations (35)
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1
Loyola University Medical Center, Foster G. McGraw Hospital and Satellites
Maywood, Illinois, United States, 60153
2
Tufts Medical Center
Boston, Massachusetts, United States, 02111
3
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
4
Siteman Cancer Center
City of Saint Peters, Missouri, United States, 63376