Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL

May 19, 2022 updated by: Peking Union Medical College Hospital

Sequential Treatment Regimens With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) as Frontline Therapy for Primary Central Nervous System Lymphoma: a Multicenter Prospective Single Arm Trial

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of sequential treatment regimens with RO-MTX after pomalidomide, orelabrutinib, rituximab (POR) in newly-diagnosed primary central nervous system lymphoma, and explore the feasibility of chemo-free treatment in PCNSL. The primary objective was the overall response rate (ORR; defined as partial response [PR] or better) after 4 cycles of POR.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There are 2 sections of this trial. Step1: the patients will be treated with 4 cycles of POR regimen （Pomalidomide 4mg d1-d14, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). The response will be evaluated every 2 cycles. The patients with PD will drop out of the study. Step2: Patients with CR/PR/SD after 4 cycles of POR treatment will be treated with 2 cycles of RO-MTX regimen（methotrexate 3.5g/m2 civ d1, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). After 6 cycles of induction therapy, all patients were followed for survival data every 12 week until disease progression, disease recurrence, death, or study termination. Patients with progression were also followed up for survival data as above. Overall survival will be followed up to 3 years after the last subject entered the study. Establishing the feasibility of chemo-free treatment in primary central nervous system lymphoma will provide the foundation for a larger study of efficacy and long-term outcomes of chemo-free therapy for patients with PCNSL.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing TianTan Hospital
        • Contact:
        • Principal Investigator:
          • Song Lin
      • Beijing, Beijing, China, 100500
        • Recruiting
        • Sanbo Brain Hospital Capital Medical University
        • Contact:
        • Principal Investigator:
          • Shouwei Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Newly diagnosed primary central nervous system lymphoma

    • Pathological type is B cell lymphoma
    • Age 18-70 years
    • Demonstrate adequate marrow hemopoietic function as defined below:WBC>3.0×109/L,ANC>1.5×109/L,HGB>90g/L,PLT>80×109/L
    • Demonstrate adequate organ function as defined below: cardiac function grade 0-2（NYHA）；SpO2>88%( natural state)；ALT<3UNL，TBil<2ULN; SCr>60ml/min/m2
    • Having at least one measurable lesions
    • Sign the Informed consent

Exclusion Criteria:

  • • The pathological diagnosis was T-cell lymphoma.

    • systemic lymphoma involved CNS
    • Pre-existing uncontrolled active infection
    • Acute myocardial infarction or unstable angina within 6 months; Uncontrolled hypertension and arrhythmia
    • Active bleeding
    • Allergic to any component of the investigational product.
    • Subjects who are suspected to be unable to comply with the study protocol
    • Pregnancy or active lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: POR-ROMTX
The experimental arm will be treated with 4 cycles of POR regimen （Pomalidomide 4mg d1-d14, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). The response will be evaluated every 2 cycles. The patients with PD will drop out of the study.Patients with CR/PR/SD after 4 cycles of POR treatment will be treated with 2 cycles of RO-MTX regimen（methotrexate 3.5g/m2 civ d1, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle).
Drug: Orelabrutinib
Orelabrutinib will be given as 150mg orally d1-d21 for 6 cycles,every 21 days for 1 cycle.
Drug: Pomalidomide
Pomalidomide will be given as 4mg d1-d14 for 4 cycles,every 21 days for 1 cycle.
Drug: Rituximab
Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol
Drug: Methotrexate
methotrexate 3.5g/m2 civ d1/cycle5-6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate
Time Frame: The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and each cycle is 21 days
ORR is defined as the proportion of patients with a best response of CR, CRu or PR
The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and each cycle is 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate
Time Frame: The ORR will be evaluated at 126 days from date of signing the informed consent , which means after 6 cycles and each cycle is 21 days
ORR is defined as the proportion of patients with a best response of CR, CRu or PR
The ORR will be evaluated at 126 days from date of signing the informed consent , which means after 6 cycles and each cycle is 21 days
complete response rate
Time Frame: The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and each cycle is 21 days
CR is defined as the proportion of patients with a best response of CR or CRu
The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and each cycle is 21 days
2 years progression-free survival
Time Frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing
From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2 years overall survival
Time Frame: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive
From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years
The occurrence of adverse events and serious adverse events
Time Frame: during follow-up, up to 2 years
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
during follow-up, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Beijing Tiantan Hospital
Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2022

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-NHL-013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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