SCCA Lymphoma Clinical Trials
Two Doses of Fostamatinib for Large B-Cell Lymphoma (UW12019)
A Randomised Double Blind Phase II Trial to Evaluate the Efficacy of Two Doses of Fostamatinib in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
| Status | Conditions | Phase | Study ID |
| Pending | Diffuse Large B-Cell Lymphoma | Phase II |
UW12019 NCT01499303 |
Summary
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).
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Eligibility Criteria (must meet the following to participate in this study)
- 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.
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 boen marrow reserve.
Last Updated
November 08, 2012See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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