Status:
COMPLETED
Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Lymphoma, B-Cell
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
Brief Summary
To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).
Eligibility Criteria
Inclusion
- CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
- Patients who have progressed after at least 1 prior chemotherapy regimen for indolent lymphoma, or 1/ 2 chemotherapy regimens, which include anthracylin or anthraquinon for aggressive lymphoma.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.
Exclusion
- Patients must not have received monoclonal antibodies or radioimmunoconjugates within 3 months before first dose of test article.
- Patients must not have received bilateral pelvic irradiation.
- Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 4 weeks before first dose of test article.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00717925
Start Date
March 1 2007
End Date
July 1 2008
Last Update
December 9 2015
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