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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|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
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)
- 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.
Hematologic Malignancies; Lymphoma; Non-Hodgkin's Lymphoma (NHL)
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