Combination Therapy With Tazemetostat in Relapsed and Refractory Peripheral T-cell Lymphoma
Plain-language summary
This trial is testing linperlisib (PI3Kδ inhibitor) combined with an EZH2 inhibitor for patients with various types of peripheral T-cell lymphoma (PTCL) who have been newly diagnosed and have not yet received treatment as well as those whose disease has come back or stopped responding to prior treatment. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. Patients are randomly assigned to different treatment groups. This trial does not currently have sites in the United States. The trial is not yet open for recruitment.
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
Tazemetostat (DRUG): Tazemetostat 800mg, twice once daily (BID), orally | Linperlisib (DRUG): In Phase I, BOIN design will be adopted to enroll 3 to 12 participants, exploring the recommended Phase II dose (RP2D) at two dose levels of Linperlisib: 60 mg once daily (QD) and 60 mg QD, orally. In Phase II, BOP2 design will be adopted to enroll around 24 participants, aiming to evaluate the efficacy and safety of Tazemetostat with Linperlisib RP2D in patients with peripheral T-cell lymphoma with co-RHOA/TET2mut. | Golidocitinib (DRUG): In Phase I, BOIN design will be adopted to enroll 3 to 12 participants, exploring the recommended Phase II dose (RP2D) at two dose levels of Lgolidocitinib: 150 mg every other day (QOD) and 150 mg QD, orally. In Phase II, BOP2 design will be adopted to enroll around 24 participants, aiming to evaluate the efficacy and safety of Tazemetostat with Golidocitinib RP2D in patients with peripheral T-cell lymphoma without co-RHOA/TET2mut.
Tazemetostat, Linperlisib, Golidocitinib
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details