Status:
COMPLETED
Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Novartis
Conditions:
T Cell Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 c...
Detailed Description
OBJECTIVES: Primary Objective To evaluate the overall response rate Secondary Objectives To assess the safety and tolerability To assess the duration of response To assess the progression free survi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00684411
Start Date
June 1 2008
End Date
October 1 2013
Last Update
January 5 2017
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115