Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma

In brief

The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.

Key facts

Study ID

NCT00868608

Run by

Pfizer

People needed

81

Starts

2009-07-30

Expected to finish

2013-06-27

Last updated by the study team

2017-10-31

Who can join

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

You may qualify if…

• Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.
• Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.
• Measurable disease with adequate bone marrow function, renal and hepatic function

You may not qualify if…

• History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
• Prior allogeneic hematopoietic stem cell transplant (HSCT).
• Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
• Loma Linda University Cancer Center — Loma Linda, California, United States
• Loma Linda University Cancer Center #5 — Loma Linda, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Facey Medical Group — Mission Hills, California, United States
• Providence Holy Cross — Mission Hills, California, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Park Nicollet Frauenshuh Cancer Center — Saint Louis Park, Minnesota, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• John Theurer Cancer Center — Hackensack, New Jersey, United States
• New York Medical College — Hawthorne, New York, United States
• Quest Diagnostics — Allentown, Pennsylvania, United States
• Carlisle Regional Medical Center Lab — Carlisle, Pennsylvania, United States
• Penn State Milton S. Hershey medical Center — Hershey, Pennsylvania, United States
• Lewistown Hospital — Lewistown, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• CMSA Medical Lab — State College, Pennsylvania, United States
• University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Universitaire Ziekenhuizen UZ Gasthuisberg — Leuven, Belgium
• Oncologisch Centrum GZA - Location St. Augustinus — Wilrijk, Belgium

Full record on ClinicalTrials.gov

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