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



Status:Completed
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/2/2017
Start Date:July 30, 2009
End Date:June 27, 2013

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A Phase 2 Study Of Inotuzumab Ozogamicin (Cmc-544) In Subjects With Indolent Non-hodgkin's Lymphoma (Nhl) That Is Refractory To Or Has Relapsed After Rituximab And Chemotherapy Or Radioimmunotherapy

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.


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.
We found this trial at
22
sites
11234 Anderson Street
Loma Linda, California 92354
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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1251 South Cedar Crest Boulevard
Allentown, Pennsylvania 18103
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Birmingham, AL
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361 Alexander Spring Road
Carlisle, Pennsylvania 17015
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Carlisle, PA
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Gent,
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Hackensack, New Jersey 07601
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hawthorne, New York 10532
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Hawthorne, NY
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Hershey, PA
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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400 Highland Ave
Lewistown, Pennsylvania 17044
(717) 248-5411
Lewistown Hospital Geisinger-Lewistown Hospital, non-profit organization, is a 123-bed acute care community hospital serving the...
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Lewistown, PA
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Loma Linda, California 92354
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Loma Linda, CA
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Mission Hills, California
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15031 Rinaldi St
Mission Hills, California 91345
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Philadelphia, Pennsylvania 19111
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Saint Louis, Missouri 63110
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis Park, Minnesota 55426
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1850 East Park Avenue
State College, Pennsylvania 16803
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