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

NCT ID: NCT00684411

Last Updated: 2017-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-10-31

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.

Conditions

T Cell Non-Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Imatinib mesylate

The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.

Group Type: EXPERIMENTAL

Imatinib mesylate

Intervention Type: DRUG

Interventions

Imatinib mesylate

Intervention Type: DRUG

Other Intervention Names

Gleevac

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Eric Jacobsen, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Jacobsen, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25012943 (View on PubMed)

Other Identifiers

08-063

Identifier Type: -

Identifier Source: org_study_id