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 |
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.
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
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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500 University Dr
Hershey, Pennsylvania 17033
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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1515 Holcombe Blvd
Houston, Texas 77030
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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Lewistown Hospital Geisinger-Lewistown Hospital, non-profit organization, is a 123-bed acute care community hospital serving the...
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Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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660 S Euclid Ave
Saint Louis, Missouri 63110
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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