264
Participants
Start Date
February 13, 2023
Primary Completion Date
July 15, 2026
Study Completion Date
July 15, 2028
CHOP+selinexor+5-Azacitidine
"Phase I: 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 of every 21-day cycle for the first cycle. If tumor NGS indicates T1 genetic subtype, for the remaining 5 cycles, they will receive 5-Azacitidine ih d-7-d-1 and selinexor 40mg or 60mg qw (d-7, 1, 8) by traditional 3+3 dose escalation methods and decide RP2D of selinexor.~Phase II: Patients will receive CHOP for the first cycle. If tumor NGS indicates T1 genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 21-day cycle."
CHOP+duvelisib+5-Azacitidine
"Phase I: 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 of every 21-day cycle for the first cycle. If tumor NGS indicates T2 genetic subtype, for the remaining 5 cycles, they will receive 5-Azacitidine ih d-7-d-1 and duvelisib 25mg or 50mg bid (d1-14) by traditional 3+3 dose escalation methods and decide RP2D of duvelisib.~Phase II: Patients will receive CHOP for the first cycle. If tumor NGS indicates T1 genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 21-day cycle."
CHOP+chidamide+tislelizumab
"Phase I: 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 of every 21-day cycle for the first cycle. If tumor NGS indicates T3 genetic subtype, for the remaining 5 cycles, they will receive tislelizumab 200mg d0 ivgtt and chidamide 20mg or 30mg biw (d1,4,8,11) by traditional 3+3 dose escalation methods and decide RP2D of chidamide.~Phase II: Patients will receive CHOP for the first cycle. If tumor NGS indicates T3 genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 21-day cycle."
standard CHOP
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 of every 21-day cycle for the 6 cycles.
RECRUITING
Ruijin hospital, Shanghai
The First Affiliated Hospital of Nanchang University
OTHER
Peking University Third Hospital
OTHER
Wuhan TongJi Hospital
OTHER
West China Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Anhui Provincial Cancer Hospital
OTHER
The First Affiliated Hospital of Soochow University
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Beijing Tongren Hospital
OTHER
Peking University People's Hospital
OTHER
Sun Yat-sen University
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
The First Hospital of Jilin University
OTHER
Ruijin Hospital
OTHER