New Genotype-guided Treatment in Newly Diagnosed PTCL
Plain-language summary
This trial is testing a genotype-guided approach that adds different targeted drugs to standard CHOP chemotherapy for patients with newly diagnosed peripheral T-cell lymphoma. The specific targeted drug (such as azacitidine plus selinexor, decitabine plus selinexor, an EZH2 inhibitor plus chidamide, or azacitidine plus a JAK inhibitor) is chosen based on the genetic subtype of the lymphoma found by NGS testing. This is a Phase 1/2 randomized trial comparing the genotype-guided combination to CHOP alone. This trial does not currently have sites in the United States.
Who can join (key eligibility)
- Age 18 Years to 75 Years years
- 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
Azacitidine plus Selinexor with CHOP (DRUG): Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 for the first cycle. If tumor NGS indicates TP53-mutated genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 28-day cycle. Patients in CHOPX2 group will receive azacitidine d-5 to d-1 and Selinexor 40mg qw combined with standard CHOP. | Decitabine plus Selinexor with CHOP (DRUG): Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 for the first cycle. If tumor NGS indicates TP53-mutated genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 28-day cycle. Patients in CHOPX2 group will receive Decitabine RP2D (confrimed by phase I) and Selinexor 40mg qw combined with standard CHOP. | Zeprumetostat plus chidamide with CHOP (DRUG): Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 for the first cycle. If tumor NGS indicates core epigenetic genes-mutated genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 28-day cycle. Patients in CHOPX2 group will receive Zeprumetostat RP2D (confrimed by phase I) and chidamide 20mg biw combined with standard CHOP. | Azacitidine plus Golidocitinib with CHOP (DRUG): Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 for the first cycle. If tumor NGS indicates other genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 28-day cycle. Patients in CHOPX2 group will receive Azacitidine ih d-5-d-1 and Golidocitinib RP2D (confirmed by Phase I) combined with standard CHOP. | CHOP (DRUG): Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 for cycle 1 to cycle 6.
Azacitidine plus Selinexor with CHOP, Decitabine plus Selinexor with CHOP, Zeprumetostat plus chidamide with CHOP, Azacitidine plus Golidocitinib with CHOP, CHOP
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details