Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma
This study has been completed.
Brigham and Women's Hospital
Information provided by (Responsible Party):
Eric Jacobsen, MD, Dana-Farber Cancer Institute
First received: May 22, 2008
Last updated: February 11, 2015
Last verified: February 2015
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.
T Cell Non-Hodgkin Lymphoma
Drug: Imatinib mesylate
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Pilot Study of Gleevec (Imatinib Mesylate) in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2014 (Final data collection date for primary outcome measure)
Experimental: Imatinib mesylate
400 mg PO once daily as continuous administration. Patients will be assessed for response at weeks 8 and 16. If a patient has stable disease or a partial response at week 8 they will be dose escalated to 600 mg PO once daily continuous dosing so long as they have not experienced any unacceptable toxicity necessitating dose reduction. If a patient has stable disease or a partial response at the week 16 visit they will dose escalated to 800 mg PO total dose daily (given as 400mg BID) continuous dosing if they were previously on 600 mg PO once daily. Patients previously on 400mg PO once daily will dose escalate to 600mg PO once daily.
Drug: Imatinib mesylate
Given orally continuously
Other Name: Gleevec
- 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684411
|Dana-Farber Cancer Institute
|Boston, Massachusetts, United States, 02115 |
Dana-Farber Cancer Institute
Brigham and Women's Hospital
||Eric Jacobsen, MD
||Dana-Farber Cancer Institute
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.
||Eric Jacobsen, MD, Principal Investigator, Dana-Farber Cancer Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 22, 2008
||February 11, 2015
||United States: Institutional Review Board
Keywords provided by Dana-Farber Cancer Institute:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2015
Immune System Diseases
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors