Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)
Phase 1
Completed
- Conditions
- Lymphoma, B-Cell
- Interventions
- Drug: Inotuzumab Ozogamicin (CMC-544)
- Registration Number
- NCT00717925
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Inotuzumab Ozogamicin (CMC-544) -
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results. 4 months
- Secondary Outcome Measures
Name Time Method Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas). 4 months