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

Completed · Phase 1/Phase 2

Conditions studied: B-Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT00299494

Run by

Pfizer

People needed

119

Starts

2006-05-04

Expected to finish

2014-06-02

Last updated by the study team

2018-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham- — Birmingham, Alabama, United States
• IDS Pharmacy — Birmingham, Alabama, United States
• University of Alabama at Birmingham- — Birmingham, Alabama, United States
• California Cancer Care, Inc. — Greenbrae, California, United States
• University of California Medical Center — San Francisco, California, United States
• California Cancer Care — San Mateo, California, United States
• Emory Clinic — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Emory University Investigational Drug Service — Atlanta, Georgia, United States
• Northwestern Medical Faculty Foundation — Chicago, Illinois, United States
• Nevada Cancer Institute- — Las Vegas, Nevada, United States
• Rosewell Park Cancer Institute — Buffalo, New York, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Gabrail Cancer Center — Dover, Ohio, United States
• UHHS - Westlake — Westlake, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
• Royal Brisbane and Women's Hospital — Herston, Brisbane, QLD, Australia
• Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven, Vlaams-brabant, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• University Hospital Gent - Department of Hematology — Ghent, Belgium
• Hôpital André MIGNOT — Le Chesnay, France
• Hôpital Saint-Louis — Paris, France

Full record on ClinicalTrials.gov

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