Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma
Condition: T Cell Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell
Intervention: Imatinib mesylate
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T NHL; Gleevec; imatinib mesylate

Summary:

      The purpose of this research study is to evaluate the overall response rate to imatinib
      mesylate in participants with relapsed or refractory T cell non-Hodgkin's lymphoma. This drug
      has been used in chronic myeloid leukemia and information from those other research studies
      suggests that it may help to treat T cell non-Hodgkin's lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed T NHL, excluding T prolymphocytic leukemia, T lymphoblastic
             lymphoma, and T/NK large granular lymphocytic leukemia.

          -  Measurable disease, defined as at least one bidimensionally measurable site of disease
             measuring at least 1.5cm in greatest diameter.

          -  Failed at least one systemic chemotherapy or biologic therapy for T cell lymphoma
             unless it can be clearly documented that the patient can not tolerate such therapy.

          -  18 years of age or older

          -  Life expectancy of greater than 3 months

          -  ECOG Performance Status of lesser then or equal to 2

          -  Normal organ and marrow function as outlined in the protocol

          -  Agree to the use of adequate contraception prior to study entry and for the duration
             of the study

        Exclusion Criteria:

          -  Chemotherapy or radiotherapy within 4 weeks prior to entering the study

          -  Receiving any other study agents

          -  CNS lymphoma requiring active therapy

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to imatinib mesylate

          -  Participants requiring concomitant administration of any medications or substances
             that are inhibitors or inducers of CYP3A4 are ineligible

          -  Patient previously received radiotherapy to 25% or greater of the bone marrow

          -  Uncontrolled intercurrent illness including but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant or lactating women

          -  History of a different malignancy except for individuals who have been disease-free
             for at least 5 years and are deemed by the investigator to be at low risk for
             recurrence of that malignancy

          -  HIV-positive individuals on combination antiretroviral therapy

          -  Known chronic liver disease

          -  Major surgery within 2 weeks prior to study entry