High-dose Methotrexate Combined with Thiotepa and Zanubrutinib in the Treatment of Newly Diagnosed PCNSL (MTZ)

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

January 1, 2028

Study Completion Date

January 1, 2028

Conditions
Primary Central Nervous System Lymphoma (PCNSL)Non Hodgkin Lymphoma (NHL)
Interventions
DRUG

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"

DRUG

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"

DRUG

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)"

Trial Locations (1)

510060

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER