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Phase 2 N=12 Treatment

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

T Cell Non-Hodgkin Lymphoma

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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