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

Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: T Cell Non-Hodgkin Lymphoma

Intervention: Imatinib mesylate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Dana-Farber Cancer Institute

Official(s) and/or principal investigator(s):
Eric Jacobsen, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute

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.

Clinical Details

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

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

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

Secondary outcome:

To assess the safety and tolerability of imatinib in patients with T NHL

To assess the duration of response in patients with T NHL treated with imatinib

To assess the progression free survival and overall survival of T NHL patients treated with imatinib

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Additional Information

Related publications:

Jacobsen E, Pozdnyakova O, Redd R, Fisher DC, Dorfman DM, Dal Cin P, LaCasce A, Armand P, Hochberg E, Cote G, Shahsafaei A, Neuberg D, Brown JR, Freedman AS. Imatinib mesylate lacks efficacy in relapsed/refractory peripheral T cell lymphoma. Leuk Lymphoma. 2015 Apr;56(4):993-8. doi: 10.3109/10428194.2014.941835. Epub 2014 Aug 20.

Starting date: June 2008
Last updated: February 11, 2015

Page last updated: August 23, 2015

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