Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)
NCT ID: NCT00299494
Last Updated: 2018-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
119 participants
INTERVENTIONAL
2006-05-04
2014-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (FOLLICULAR)
Follicular
inotuzumab ozogamicin
IV, 1.8 mg/m2, q4w
Rituximab
rituximab 375 mg/m\^2 via IV infusion on Day 1
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (DLBCL)
Diffuse Large B-cell Lymphoma
inotuzumab ozogamicin
IV, 1.8 mg/m2, q4w
Rituximab
rituximab 375 mg/m\^2 via IV infusion on Day 1
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (REFRACTORY)
Refractory Aggressive NHL
inotuzumab ozogamicin
IV, 1.8 mg/m2, q4w
Rituximab
rituximab 375 mg/m\^2 via IV infusion on Day 1
Interventions
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inotuzumab ozogamicin
IV, 1.8 mg/m2, q4w
inotuzumab ozogamicin
IV, 1.8 mg/m2, q4w
inotuzumab ozogamicin
IV, 1.8 mg/m2, q4w
Rituximab
rituximab 375 mg/m\^2 via IV infusion on Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior therapy must contain at least one course of rituximab therapy, as single agent or in combination.
* Measurable disease.
Exclusion Criteria
* Subjects must not have received previous radioimmunotherapy.
* Subjects who have undergone a prior bone marrow transplantation within the last 6 months.
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 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
CH Lyon Sud
Pierre-Bénite, , France
Universitaetsklinik Bonn, Medizinische Klinik und Poliklinik III
Bonn, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet, III. medizinische klinik und Poliklinik
Mainz, , Germany
Prince Of Wales Hospital
Shatin N.T., HONG KONG, Hong Kong
Universita La Sapienza Cattedra di Ematologia
Roma, , Italy
Erasmus Medisch Centrum--
Rotterdam, South Holland, Netherlands
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warsaw, , Poland
Asan Medical Center
Seoul, , South Korea
Hospital Clinic I Provincial de Barcelona
Barcelona, , Spain
University Hospital Zurich
Zurich, , Switzerland
Derriford Hospital - Plymouth
Plymouth, Devon, United Kingdom
Somers Cancer Science Building MP824
Southampton, Hampshire, United Kingdom
Bart's Cancer Institute; Queen Mary University of London
London, , United Kingdom
Countries
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References
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Fayad L, Offner F, Smith MR, Verhoef G, Johnson P, Kaufman JL, Rohatiner A, Advani A, Foran J, Hess G, Coiffier B, Czuczman M, Gine E, Durrant S, Kneissl M, Luu KT, Hua SY, Boni J, Vandendries E, Dang NH. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J Clin Oncol. 2013 Feb 10;31(5):573-83. doi: 10.1200/JCO.2012.42.7211. Epub 2013 Jan 7.
Related Links
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Other Identifiers
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B1931004
Identifier Type: OTHER
Identifier Source: secondary_id
2005-005436-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3129K3-101
Identifier Type: -
Identifier Source: org_study_id
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