Non Hodgkin Lymphoma Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

81

Study ID:

NCT00868608

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 33 Locations for this study

See Locations Near You

University of Alabama Birmingham
Birmingham Alabama, 35294, United States
University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
Loma Linda University Cancer Center
Loma Linda California, 92350, United States
Loma Linda University Cancer Center #5
Loma Linda California, 92354, United States
Loma Linda University Medical Center
Loma Linda California, 92354, United States
Facey Medical Group
Mission Hills California, 91345, United States
Providence Holy Cross
Mission Hills California, 91345, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park Minnesota, 55426, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
John Theurer Cancer Center
Hackensack New Jersey, 07601, United States
New York Medical College
Hawthorne New York, 10532, United States
Quest Diagnostics
Allentown Pennsylvania, 18103, United States
Carlisle Regional Medical Center Lab
Carlisle Pennsylvania, 17015, United States
Penn State Milton S. Hershey medical Center
Hershey Pennsylvania, 17033, United States
Lewistown Hospital
Lewistown Pennsylvania, 17044, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
CMSA Medical Lab
State College Pennsylvania, 16803, United States
University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Universitaire Ziekenhuizen UZ Gasthuisberg
Leuven , 3000, Belgium
Oncologisch Centrum GZA - Location St. Augustinus
Wilrijk , 2610, Belgium
Charite Campus Mitte
Berlin , 10117, Germany
Charite Berlin-Campus Virchow-Klinikum
Berlin , 13353, Germany
The Chinese University of Hong Kong, Prince of Wales Hospital
Shatin, N.T. , , Hong Kong
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Belgyogyaszati Intezet,
Debrecen , 4012, Hungary
Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
Kaposvar , 7400, Hungary
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
EPMint Co., Ltd
Aichi , 460-0, Japan
Nagoya Daini Red Cross Hospital
Aichi , 466-8, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka , 811-1, Japan
National Hp. Org. Kyushu Medical Center
Fukuoka , , Japan
Tokai University Hospital
Kanagawa , 259-1, Japan
Cancer Inst. Hp. of Japanese Foundation for Cancer Research
Tokyo , 135-8, Japan
Samsung Medical Center
Seoul Korea, 135-7, Korea, Republic of
Erasmus Medisch Centrum
Rotterdam , 3015 , Netherlands
Erasmus MC Apotheek
Rotterdam , 3015 , Netherlands
Singapore General Hospital
Singapore , 169 6, Singapore

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

81

Study ID:

NCT00868608

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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