Study of Tazemetostat in Lymphoid Malignancies (NCT05983965) | Clinical Trial Compass
TerminatedPhase 1
Study of Tazemetostat in Lymphoid Malignancies
Stopped: Ipsen, drug company requested all studies using the drug Taxemetostat be terminated due to increased risk of secondary malignancies in subjects.
United States6 participantsStarted 2024-09-05
Plain-language summary
Tazemetostat is an oral EZH2 inhibitor which has been FDA approved for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment option. We propose a study to evaluate the safety of tazemetostat in relapsed / refractory peripheral T-cell lymphoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed peripheral T-cell lymphomas (PTCL) with allowed subtypes listed below as per the revised World Health Organization 2022 classification \[6\]:
✓. PTCL-not otherwise specified (NOS)
✓. Nodal T-follicular helper cell lymphoma - angioimmunoblastic type, follicular type, or NOS
✕. Prior allogeneic stem cell transplant within 6 months. The patient should not have any active GVH or should be on immune suppressive agents.
✕. Completion of treatment with any radiotherapy, chemotherapy, antibody, immunoconjugates and/or another investigational drug ≤4 weeks (or 5 half-lives of the drug, whichever is shorter) prior to first dose of study drug. Patients may be enrolled after a minimum of 2 weeks of radiation if radiation was for palliative intent.
✕. Prior therapy with an EZH2 inhibitor.
✕. Inability to swallow and retain oral medications.
✕. Pregnant women are excluded from this study.
✕. Any active, concurrent, significant illness or disease (other underlying lymphoma) or clinically significant findings including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the patient from participation in the study such as: