Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)

• Status: Completed
• Trial end date: 2014-06-02
• Target enrollment: 0
• Participant gender: All

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 ozogamicin [CMC-544] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: UCB Pharma
• Treatments: Inotuzumab Ozogamicin; Rituximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.