Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer

Completed · Phase 2

Conditions studied: Diffuse Large B-Cell Lymphoma

In brief

This study will evaluate the effectiveness of fostamatinib (200 mg twice a day) in patients with worsening or unmanageable lymphoma with a specific type of lymphoma called Diffuse Large B-Cell Lymphoma (abbreviated as DLBCL)

Key facts

Study ID

NCT01499303

Run by

AstraZeneca

People needed

101

Starts

2011-12-01

Expected to finish

2013-10-01

Last updated by the study team

2014-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged at least 18 years of age.
• 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.

You may not qualify if…

• Treatment with nitrosurea, mitomycin C, investigational agents or study drugs w/in28 days of first dose of study treatment, any other chemotherapy, immunotherapy or anticancer agents w/in 3 weeks of first dose of study treatment, previous fostamatinib.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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