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Trial record 1 of 1 for:    NCT01499303
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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):
AstraZeneca Identifier:
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)

Condition Intervention Phase
Diffuse Large B-Cell Lymphoma Drug: Fostamatinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma(DLBCL)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: Week 8 ]
    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.

Enrollment: 101
Study Start Date: December 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fostamatinib 200
200mg fostamatinib bid n=60
Drug: Fostamatinib
Phase II Trial to evaluate the efficacy of 200mg fostamatinib

Detailed Description:
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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01499303

  Show 21 Study Locations
Sponsors and Collaborators
Study Director: Bernadette Weidman, RN, MSN, PMP Sponsor GmbH
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT01499303     History of Changes
Other Study ID Numbers: D4302C00001
Study First Received: December 19, 2011
Results First Received: June 17, 2014
Last Updated: August 8, 2014

Keywords provided by AstraZeneca:
Diffuse Large B-Cell Lymphoma (DLBCL)

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin processed this record on September 18, 2017