30
Participants
Start Date
January 1, 2025
Primary Completion Date
January 1, 2028
Study Completion Date
January 1, 2028
Zanubrutinib , Thiotepa
"First 1-4 cycle~Drug: Thiotepa~* 40mg/m2,d1 each 21-day cycle from cycle 1 for up to 4 cycle Drug: Zanubrutinib~* Zanubrutinib will be given at a dose of 160mg,bid,d1-d21"
Methotrexate , Thiotepa and Zanubrutinib
"Cycle 5 - 10 Drug: Methotrexate~* Intravenous methotrexate at 3.5g/m2 for 6 hours will be given on day 1 each 21-day cycle 【Leucovorin Calcium (CF): 15mg/m², rescue begins 12 hours after the infusion of methotrexate (MTX) ends, administered every 6 hours until the MTX plasma concentration is ≤ 0.1 μmol·L-¹ at 48 hours; plasma concentration monitoring time points: 0, 6, 24, 48, 72 hours.】 Other Names: MTX Drug: Thiotepa~* 40mg/m2,d1 each 21-day cycle from cycle 5 for up to 10 cycle Drug: Zanubrutinib Zanubrutinib will be given at a dose of 160mg,bid,d1-d21"
ASCT±Zanubrutinib
"Consolidation / maintenance treatment Patients who achieve a Complete Response (CR) or Partial Response (PR) after the ZT/ZMT treatment will enter consolidation/maintenance therapy.~Patients age ≤65 years old will undergo Autologous Stem Cell Transplantation (ASCT, with a recommended conditioning regimen that includes Thiotepa), followed by 6 months of maintenance treatment with zanubrutinib.~Patients age \> 65 will receive 6 months of maintenance treatment with zanubrutinib.~\*The study permits the prophylactic use of Granulocyte Colony-Stimulating Factor (G-CSF). For detailed usage, please refer to the guidelines from the National Comprehensive Cancer Network (NCCN) or the Chinese Society of Clinical Oncology (CSCO)"
Sun Yat-sen University Cancer Center, Guangzhou
Sun Yat-sen University
OTHER