Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma
Condition: T Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: Fostamatinib Disodium
Intervention description: 200 mg PO BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T Cell Lymphoma; Lymphoma

Summary:

      Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19
      patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients
      exhibit a response at Week 8 or later in the study. All enrolled patients will be treated
      with Fostamatinib Disodium until disease progression. Efficacy will be assessed by tumor
      measurements using CT and PET (when indicated) scans and physical exam at baseline, and scans
      and physical exam of all disease-involved areas every 8 weeks until progression. Safety will
      be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All
      patients will have a follow-up visit 30 days following last study drug treatment. Blood
      samples for PK assessment will be obtained from all patients enrolled in Stage 1 at protocol
      defined intervals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must give written informed consent to participate in this study by signing an
             IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.

          -  Males and females, 18 years of age or older.

          -  Patients must have histologically proven T-cell lymphoma (TCL).

          -  Patients must have documented disease progression after receiving at least one prior
             therapeutic regimen and must be patients for whom no known curative therapy exists.

        Exclusion Criteria:

          -  Patient has a history of, or a concurrent, clinically significant illness, medical
             condition or laboratory abnormality that, in the investigator's opinion, could affect
             the conduct of the study.

          -  Has a B-cell lymphoma, primary CNS lymphoma, or known lymphomatous involvement of the
             CNS, or any other NK/T-cell leukemia/lymphoma.

          -  Has uncontrolled or poorly controlled hypertension.

          -  Has had recent (within 1 month prior to Day 1) serious surgery or uncontrolled
             infectious disease.

          -  Has any concurrent malignancy requiring treatment.

          -  Has a known positive test for Hepatitis B surface Ag, Hepatitis C, or HIV.

          -  Has laboratory abnormalities.

          -  Has difficulty swallowing or malabsorption.

          -  Has an ECOG performance status > 2.

          -  Has not recovered from adverse effects related to last prior therapy for lymphoma.

          -  Has had an allotransplantation within 90 days prior to Day 1 of treatment.

          -  Has been treated with a CYP3A4 inducer/inhibitor within 3 days prior to Day 1 of
             treatment or is expected to require treatment with CYP3A4 inducer/inhibitor during the
             course of the study.

          -  Has received systemic steroids at a dose greater than the equivalent of 10 mg/day of
             prednisone within 7 days prior to Day 1 of treatment.

          -  Has received any other investigational therapy within 5 half-lives of the agent or 2
             weeks of Day 1 of treatment, whichever is longer.

          -  Is a female of childbearing potential unless menopausal, surgically sterile, or
             willing to use an effective method of birth control, (oral contraceptive, mechanical
             barrier, long-acting hormonal agent), during the study and for 30 days thereafter.

          -  Is pregnant or lactating.