Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer
NCT ID: NCT01499303
Last Updated: 2014-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2011-12-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fostamatinib 200
200mg fostamatinib bid n=60
Fostamatinib
Phase II Trial to evaluate the efficacy of 200mg fostamatinib
Interventions
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Fostamatinib
Phase II Trial to evaluate the efficacy of 200mg fostamatinib
Eligibility Criteria
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Inclusion Criteria
* Patients with relapsed or refractory diffuse large B-cell lymphoma who have previously received R-CHOP (or equivalent) chemo-immunotherapy and high dose chemotherapy with stem cell rescue, or who are ineligible for high dose therapy with stem cell rescue.
* Measurable disease as defined by Cheson et al 2007 criteria.
* One fresh pre-treatment excisional or core needle biopsy from suitable and accessible site.
* World Health Organization (WHO) performance status 0 to 1.
Exclusion Criteria
* With the exception of alopecia, any unresolved toxicities from prior therapy or surgery greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
* Uncontrolled hypertension (defined as \>140mmHg systolic and/or \> 90 mmHG diastolic at baseline with or without antihypertensive therapy.
* Evidence of tuberculosis (TB).
* Inadequate boen marrow reserve.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bernadette Weidman, RN, MSN, PMP
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Research Site
Huntsville, Alabama, United States
Research Site
Denver, Colorado, United States
Research Site
New Haven, Connecticut, United States
Research Site
Sarasota, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Iowa City, Iowa, United States
Research Site
Baltimore, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Rochester, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Hackensack, New Jersey, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
Research Site
Columbus, Ohio, United States
Research Site
Nashville, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Charlottesville, Virginia, United States
Research Site
Seattle, Washington, United States
Research Site
London, , United Kingdom
Research Site
Southampton, , United Kingdom
Countries
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Related Links
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Other Identifiers
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D4302C00001
Identifier Type: -
Identifier Source: org_study_id
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