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

This study is ongoing, but not recruiting participants.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00717925

Purpose

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

Condition	Intervention	Phase
Lymphoma, B-Cell	Drug: Inotuzumab Ozogamicin (CMC-544)	Phase I

MedlinePlus related topics: Lymphoma

Drug Information available for: Inotuzumab ozogamicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1 Study of CMC-544 Administered as a Single Agent in Subjects With B-Cell Non-Hodgkin's Lymphoma

Further study details as provided by Wyeth:

Primary Outcome Measures:

Safety: physical examinations (with vital signs) and laboratory test measurements. [ Time Frame: Approximately 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy: tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas). [ Time Frame: Approximately 4 months ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	March 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Inotuzumab Ozogamicin (CMC-544)

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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. 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717925

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3129K1-103
Study First Received:	July 16, 2008
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00717925
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth:

B-cell Non-Hodgkin's Lymphoma
NHL

Study placed in the following topic categories:

Antibodies, Monoclonal
Lymphoma, B-Cell
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
B-cell lymphomas

Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors

Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009