Status:
COMPLETED
Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the effectiveness of fostamatinib (200 mg twice a day) in patients with worsening or unmanageable lymphoma with a specific type of lymphoma called Diffuse Large B-Cell Lymphom...
Detailed Description
Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01499303
Start Date
December 1 2011
End Date
October 1 2013
Last Update
August 22 2014
Active Locations (21)
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1
Research Site
Huntsville, Alabama, United States
2
Research Site
Denver, Colorado, United States
3
Research Site
New Haven, Connecticut, United States
4
Research Site
Sarasota, Florida, United States