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

NCT06646211 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-17

No results posted yet for this study

Summary

This is a phase Ⅱ clinical study of Zanubrutinib(Z) in combination with methotrexate (M) and thiotepa(T) in treating newly diagnosed primary CNS lymphoma (PCNSL).

The purpose of the study is to test the efficacy and tolerability of a combination treatment of MTZ regimen in treating patients who have newly diagnosed PCNSL

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)

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2028-01-01
Completion
2028-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06646211 on ClinicalTrials.gov