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A Pilot Study of Gleevec (Imatinib Mesylate) in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma

18 Years
Open (Enrolling)
T Cell Non-Hodgkin Lymphoma

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Trial Information

A Pilot Study of Gleevec (Imatinib Mesylate) in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma

- Participants will take the study drug orally each day of each eight week treatment

- During all treatment cycles, participants will have a physical exam and will be asked
questions about their general health and specific questions about any problems they
might be having and any medications they may be taking.

- If the participant has skin lesion, photographs will be taken of the skin lesion to
assess the response of the tumor to study treatment. CT scans will be used to follow
the participants response to treatment.

- Blood tests, including chemistry, hematology, and other tests to measure any additional
effect of the study drug and disease status will also be performed.

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

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the overall response rate of imatinib in patients with T NHL

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Eric Jacobsen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

June 2008

Completion Date:

November 2014

Related Keywords:

  • T Cell Non-Hodgkin Lymphoma
  • T NHL
  • Gleevec
  • imatinib mesylate
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell



Dana-Farber Cancer Institute Boston, Massachusetts  02115