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

Purpose

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.

Condition	Intervention
T Cell Non-Hodgkin Lymphoma	Drug: Imatinib mesylate

MedlinePlus related topics:

Cancer Lymphoma

ChemIDplus related topics:

Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To evaluate the overall response rate of imatinib in patients with T NHL [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety and tolerability of imatinib in patients with T NHL [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
To assess the duration of response in patients with T NHL treated with imatinib [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To assess the progression free survival and overall survival of T NHL patients treated with imatinib [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Given orally continuously

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684411

Contacts


Contact: Eric Jacobsen, MD	617-632-6633	Eric_Jacobsen@dfci.harvard.edu

Contact: Hazel Reynolds	617-632-6840

Locations


United States, Massachusetts
	Dana-Farber Cancer Institute	Recruiting
	Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Novartis

Investigators


Principal Investigator:	Eric Jacobsen, MD	Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Eric Jacobsen, MD )
Study ID Numbers:	08-063
First Received:	May 22, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00684411
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

T NHL

Gleevec

imatinib mesylate

Study placed in the following topic categories:

Imatinib

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, T-Cell

Lymphoma, small cleaved-cell, diffuse

Lymphoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Novartis
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00684411