Phase 2 Completed N=68 Treatment

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

Diffuse Large B-Cell Lymphoma

Source: ClinicalTrials.gov NCT01499303 ↗

Enrolled (actual)

Serious AEs

22.1%

Results posted

Aug 2014

Primary outcomePrimary: Objective Response Rate — 2; 0 Patients

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 Lymphoma (abbreviated as DLBCL)

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response Rate	2; 0	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01499303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.