OncoMatch/Clinical Trials/NCT05983965
Study of Tazemetostat in Lymphoid Malignancies
Is NCT05983965 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Tazemetostat for t-cell lymphoma.
Treatment: Tazemetostat — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: any prior therapy for PTCL
Patients received at least 1 prior therapy for PTCL. Patients must have relapsed or refractory disease.
Cannot have received: EZH2 inhibitor
Prior therapy with an EZH2 inhibitor
Cannot have received: autologous hematopoietic stem cell transplantation
Exception: allowed if >3 months prior to first dose
Completion of an autologous hematopoietic stem cell transplantation within 3 months prior to first dose of study drug
Cannot have received: allogeneic stem cell transplant
Exception: allowed if >6 months prior and no active GVH or on immune suppressive agents
Prior allogeneic stem cell transplant within 6 months. The patient should not have any active GVH or should be on immune suppressive agents.
Cannot have received: radiotherapy, chemotherapy, antibody, immunoconjugates, or investigational drug
Exception: allowed if >4 weeks (or 5 half-lives, whichever is shorter) prior to first dose; radiation for palliative intent allowed after minimum of 2 weeks
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.
Lab requirements
Blood counts
ANC ≥ 1,000/µL, Platelet Count ≥ 75,000/ µL, Hemoglobin ≥ 8.0 g/dl
Kidney function
CrCl > 30ml/min using Cockroft-Gault, based on actual weight
Liver function
No more than moderate hepatic impairment per NCI ODWG criteria - Total bilirubin ≤ 3X ULN, AST ≤ ULN (unless attributed to fatty liver or disease involvement)
Cardiac function
Left ventricular ejection fraction (LVEF) defined by MUGA scan or echocardiogram within the institutional limits of normal
Adequate organ function as defined below unless attributed to disease involvement (Note: transfusions and growth factors allowed during screening; however, transfusion-dependency defined as requiring blood products ≥once per week not allowed): Liver function: No more than moderate hepatic impairment per NCI ODWG criteria - Total bilirubin ≤ 3X ULN, AST ≤ ULN (unless attributed to fatty liver or disease involvement). Kidney function: CrCl > 30ml/min using Cockroft-Gault, based on actual weight. ANC ≥ 1,000/µL, Platelet Count ≥ 75,000/ µL, Hemoglobin ≥ 8.0 g/dl. Left ventricular ejection fraction (LVEF) defined by multiple-gated acquisition (MUGA) scan or echocardiogram within the institutional limits of normal.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify