Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab

• Status: Completed
• Trial end date: 2010-03-10
• Target enrollment: 0
• Participant gender: All

Summary

To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).

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

Details

• Lead Sponsor: Pfizer
• Treatments: Inotuzumab Ozogamicin; Rituximab

Criteria

Inclusion Criteria:

• CD20 and CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.

• Prior therapy must have contained at least one dose of Rituximab therapy. Patients can not be refractory to Rituximab (refractory = PD under treatment or within 6 month

• Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.

• Patients must not have received previous radioimmunotherapy.

• Patients tolerant to Rituximab.

• Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 28 days before first dose of test article.

Exclusion Criteria:

• Candidate for potentially curative therapies

• Subjects must not have received previous radioimmunotherapy.

• Subjects with autologous hematopoietic stem cell transplant within the last 6 months