Status:
COMPLETED
Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Pfizer
Collaborating Sponsors:
UCB Pharma
Conditions:
B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamic...
Eligibility Criteria
Inclusion
- Subjects with CD20 and CD22-positive, follicular or diffuse large B-cell NHL who have not responded or progressed after 1 or 2 prior therapies; or subjects with CD20 and CD22-positive intermediate/aggressive NHL (diffuse large B-cell, mantle cell, transformed follicular or follicular grade 3b NHL) who have not responded or progressed after 1 or more prior therapies and are refractory to a previous rituximab containing therapy.
- Prior therapy must contain at least one course of rituximab therapy, as single agent or in combination.
- Measurable disease.
Exclusion
- Subjects who are candidates for other potentially curative therapies.
- Subjects must not have received previous radioimmunotherapy.
- Subjects who have undergone a prior bone marrow transplantation within the last 6 months.
Key Trial Info
Start Date :
May 4 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2014
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00299494
Start Date
May 4 2006
End Date
June 2 2014
Last Update
March 8 2018
Active Locations (38)
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1
University of Alabama at Birmingham-
Birmingham, Alabama, United States, 35249 - 3300
2
IDS Pharmacy
Birmingham, Alabama, United States, 35249
3
University of Alabama at Birmingham-
Birmingham, Alabama, United States, 35294
4
California Cancer Care, Inc.
Greenbrae, California, United States, 94904