Clinical trial NCT00684411: Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma
Official title: A Pilot Study of Gleevec (Imatinib Mesylate) in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: T Cell Non-Hodgkin Lymphoma
Keywords: T NHL
Gleevec
imatinib mesylate
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Novartis
First posted: 2008-05-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 chronic myeloid leukemia and information from those other research studies suggests that it may help to treat T cell non-Hodgkin's lymphoma.

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 survival and overall survival

STATISTICAL DESIGN:

This trial will use a single stage design to differentiate a \>/= 25% response rate from a \</= 5% rate. If observed data is consistent with the alternative response rate of 25%, imatinib would be deemed clinically interesting and worthy of a larger phase II study.

Eligibility 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: Disease was evaluated radiologically at baseline, weeks 8, 16, 24 and every 12 weeks thereafter on treatment. Treatment duration was a median of 56 days (range 5-253 days).
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: Disease was evaluated radiologically at baseline, on treatment at weeks 8, 16, 24 and every 12 weeks thereafter, off treatment for 6 weeks or until death, whichever occurs first. Treatment duration was a median of 56 days (range 5-253 days).
measure: Overall Survival
timeFrame: Participants were followed long-term for survival for the earlier of 6 weeks from the end of treatment or death. Maximum follow-up was 288 days in this study cohort.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Eric Jacobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.