Study to Learn if Two Doses of a Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer
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)
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital
Ann LaCasce, MD,
Dana-Farber Cancer Institute
Robin Joyce, MD,
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute:
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
- 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
- World Health Organization (WHO) performance status 0 to 1.
- 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
- 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.