Phase 2
N=12
Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma
T Cell Non-Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00684411 ↗Enrolled (actual)
12
Serious AEs
41.7%
Results posted
Jan 2017
Primary outcome: Primary: Overall Response Rate — 0.0 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Imatinib mesylate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
0.0 | — |
| SECONDARY Progression-Free Survival |
21 | — |
| SECONDARY Overall Survival |
154 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00684411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.