Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Novartis
• Treatments: Imatinib Mesylate

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