Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma
NCT ID: NCT00868608
Last Updated: 2017-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
81 participants
INTERVENTIONAL
2009-07-30
2013-06-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Study Groups
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inotuzumab ozogamicin
inotuzumab ozogamicin
Inotuzumab Ozogamicin (CMC-544)
Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles
Interventions
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Inotuzumab Ozogamicin (CMC-544)
Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Prior allogeneic hematopoietic stem cell transplant (HSCT).
* Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Charite Campus Mitte
Berlin, , Germany
Charite Berlin-Campus Virchow-Klinikum
Berlin, , 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, , Hungary
Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
Kaposvár, , Hungary
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
EPMint Co., Ltd
Aichi, , Japan
Nagoya Daini Red Cross Hospital
Aichi, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
National Hp. Org. Kyushu Medical Center
Fukuoka, , Japan
Tokai University Hospital
Kanagawa, , Japan
Cancer Inst. Hp. of Japanese Foundation for Cancer Research
Tokyo, , Japan
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Erasmus MC Apotheek
Rotterdam, , Netherlands
Singapore General Hospital
Singapore, , Singapore
Samsung Medical Center
Seoul, Korea, South Korea
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1931007
Identifier Type: OTHER
Identifier Source: secondary_id
2008-001635-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3129K7-2001
Identifier Type: -
Identifier Source: org_study_id