Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer
This study has been completed.
Information provided by (Responsible Party):
First received: December 19, 2011
Last updated: August 8, 2014
Last verified: August 2014
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)
Diffuse Large B-Cell Lymphoma
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma(DLBCL)
Primary Outcome Measures:
- Objective Response Rate [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Patients were assessed using the revised response criteria for malignant lymphoma (Cheson). Patients were assessed for response, with CT and FDG-PET scans at 8 weeks, then every 12 weeks until radiological progression by clinical CT. Complete response (CR) was defined as disappearance of all target and non-target lesions in the liver and spleen and all lymph node masses regressed to normal size. Partial response (PR) was defined as ≥50% reduction in sum of the product of the diameters (SPD) for measured lymph nodes, splenic and liver lesions separately compared to baseline SPD. Objective response rate (CR + PR) analysis, exact binomial test, primary analysis.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2013 (Final data collection date for primary outcome measure)
Experimental: Fostamatinib 200
200mg fostamatinib bid n=60
Phase II Trial to evaluate the efficacy of 200mg fostamatinib
Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01499303
||Bernadette Weidman, RN, MSN, PMP
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 19, 2011
|Results First Received:
||June 17, 2014
||August 8, 2014
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Federal Government
United States: Food and Drug Administration
Keywords provided by AstraZeneca:
Diffuse Large B-Cell Lymphoma (DLBCL)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Immune System Diseases