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

ConditionsPrimary Central Nervous System Lymphoma (PCNSL)Non Hodgkin Lymphoma (NHL)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and woman who are 18 to 70 years of age

Histologically documented PCNSL

ECOG performance status ≤ 2

Life expectancy of > 3 months

Disqualifiers

Received curative treatment and has no known active disease at least 3 years or more before screening for enrollment.

Fully treated non-melanoma skin cancer or malignant lentigo, with no evidence of disease.

Fully treated carcinoma in situ, with no evidence of disease currently.

Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure (New York Heart Association > Class 2), unstable angina, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification

Trial design

Design model

Single group

Treatments tested in this trial

  • Zanubrutinib , Thiotepa

    Drug

    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

    Drug

    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

    Drug

    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)

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Participant Group/Arm： Experimental: Methotrexate , Thiotepa and Zanubrutinib(MTZ)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR) at the end of TZ / MTZ treatment, Investigator-Assessed

The overall response rate (ORR) including complete response (CR), and partial response (PR) according to the 2005 Response Criteria of the International Primary CNS Lymphoma Collaborative Group (IPCG)

Time frame
12 month

Secondary outcomes

1

Overall Response Rate (ORR) at the end of TZ treatment, Investigator-Assessed

The overall response rate (ORR) including complete response (CR), and partial response (PR) according to the 2005 Response Criteria of the International Primary CNS Lymphoma Collaborative Group (IPCG)

Time frame
12 month
2

Duration of response（DOR）

Duration of response is defined as the time from the date of first occurrence of CR or PR to the date of the first documented PD or death due to any cause.

Time frame
12 month
3

Progression-free survival (PFS)

defined as the time from treatment to disease progression or death from any cause.

Time frame
12 month
4

Overall survival (OS)

defined as the time from treatment to death from any cause

Time frame
12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: