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

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 2

Conditions: T Cell Non-Hodgkin Lymphoma

Treatments: Drug: Imatinib mesylate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00684411

08-063

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Imatinib mesylate

Experimental group

Description:

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.

Treatment:

Drug: Imatinib mesylate