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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Diffuse Large B-Cell Lymphoma

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Trial Information

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage patients with a complete response (CR)or partial response (PR) using the revised response criteria for malignant lymphoma (Cheson et al 2007)

Outcome Time Frame:

From randomization until disease progression (expected duration of treatment approximately 6 months)

Safety Issue:

No

Principal Investigator

Jeffrey Skolnik, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sponsor GmbH

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D4302C00001

NCT ID:

NCT01499303

Start Date:

December 2011

Completion Date:

December 2013

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • lymphoma
  • DLBCL
  • fostamatinib
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Research SiteAlabaster, Alabama  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteAmes, Iowa  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteAlexandria, Minnesota  
Research SiteBranson, Missouri  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteAkron, Ohio  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington