Zeprumetostat, Azacitidine Combined With Lipo-MIT in R/R PTCL
Plain-language summary
This Phase 2 trial is evaluating Zeprumetostat, Azacitidine (AZA), and other medications as a treatment for people newly diagnosed with T-cell lymphoma. The study measures how well this treatment works and monitors for side effects. This trial does not currently list US sites.
Who can join (key eligibility)
- Age 18 Years or older
- Newly diagnosed, not yet treated
- Must be well enough for treatment (adequate performance status)
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
Zeprumetostat (DRUG): Zeprumetostat is an oral, selective Enhancer of Zeste Homolog 2 (EZH2) inhibitor. EZH2 is a histone methyltransferase often dysregulated in lymphomas. By inhibiting EZH2, zeprumetostat modulates epigenetic programming to reverse aberrant gene silencing, induce cell cycle arrest and apoptosis. In this study, it is administered at 350 mg orally twice daily continuously. It is used both in the 6-cycle induction combination phase and as monotherapy in the up to 2-year maintenance phase for responding patients. | Azacitidine (AZA) (DRUG): Azacitidine is a DNA methyltransferase inhibitor (hypomethylating agent). As a cytidine analog, it incorporates into DNA and RNA, leading to DNA hypomethylation, reactivation of silenced tumor suppressor genes, and direct cytotoxicity. In this study, azacitidine is administered at 100 mg via subcutaneous injection once daily on Days 1-5 of each 21-day induction cycle. It is part of the initial triple-drug induction regimen and is not used during the subsequent maintenance phase. | Mitoxantrone Hydrochloride Liposome (DRUG): Mitoxantrone Hydrochloride Liposome is a liposomal formulation of the anthracenedione chemotherapy agent mitoxantrone. The liposomal encapsulation aims to improve pharmacokinetics and tissue distribution. Its mechanism involves intercalating into DNA and inhibiting topoisomerase II, causing DNA strand breaks and cell death. In this study, it is administered intravenously at 16 mg/m² on Day 1 of each 21-day induction cycle. It is used only in the initial 6-cycle combination induction phase.
- Drugs / treatments
- Zeprumetostat, Azacitidine (AZA), Mitoxantrone Hydrochloride Liposome
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details