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

Status: Recruiting
Phase:
Diagnosis: Non-Hodgkin's Lymphoma
NCT ID: NCT01499303 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-158

 

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)

 

Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital

Overall PI:
Ann LaCasce, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Robin Joyce, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Kathleen McDermott, kmcdermott@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - 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. Exclusion Criteria: - 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.
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