Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer



Status:Completed
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/16/2013
Start Date:December 2011
End Date:December 2013
Contact:AstraZeneca Clinical Study Information
Email:information.center@astrazeneca.com
Phone:800-236-9933

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Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma(DLBCL)


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 Lymphoma (abbreviated as DLBCL)


Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or
Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

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.
We found this trial at
17
sites
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Teaneck, NJ
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