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

Complete title: A Phase II Trial to Evaluate the Efficacy of Fostamatinib inPatients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Research Study Number       20111975
    
Principal Investigator       Andrei Shustov, MD
    
Phase       II

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Research Study Description

This study will evaluate the effectiveness of two doses of fostamatinib (100 mg twice a day and 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)

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- 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.

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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 bone marrow reserve.

Other exclusion criteria may apply.



Research Study Number       20111975
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Hematologic Malignancies; Lymphoma; Non-Hodgkin's Lymphoma (NHL)

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