Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Inotuzumab Ozogamicin

Criteria

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.