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

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-17
• Study First Posted: 2008-07-18
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-09

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