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

Primary Purpose

Primary Central Nervous System Lymphoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Orelabrutinib

Pomalidomide

Rituximab

Methotrexate

About this trial

This is an interventional treatment trial for Primary Central Nervous System Lymphoma focused on measuring Orelabrutinib, Pomalidomide, Rituximab, primary central nervous system lymphoma, methotrexate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing TianTan HospitalRecruiting
Sanbo Brain Hospital Capital Medical UniversityRecruiting
Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

POR-ROMTX

Arm Description

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).

Outcomes

Primary Outcome Measures

overall response rate

ORR is defined as the proportion of patients with a best response of CR, CRu or PR

Secondary Outcome Measures

overall response rate

ORR is defined as the proportion of patients with a best response of CR, CRu or PR

complete response rate

CR is defined as the proportion of patients with a best response of CR or CRu

2 years progression-free survival

2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing

2 years overall survival

2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive

The occurrence of adverse events and serious adverse events

Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.

Full Information

NCT ID

NCT05390749

First Posted

May 11, 2022

Last Updated

May 19, 2022

Sponsor

Peking Union Medical College Hospital

Collaborators

Beijing Tiantan Hospital, Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05390749

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 11, 2022 (Actual)

Primary Completion Date

April 1, 2024 (Anticipated)

Study Completion Date

April 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

Beijing Tiantan Hospital, Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Central Nervous System Lymphoma

Keywords

Orelabrutinib, Pomalidomide, Rituximab, primary central nervous system lymphoma, methotrexate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

POR-ROMTX

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Orelabrutinib

Intervention Description

Orelabrutinib will be given as 150mg orally d1-d21 for 6 cycles,every 21 days for 1 cycle.

Intervention Type

Drug

Intervention Name(s)

Pomalidomide

Intervention Description

Pomalidomide will be given as 4mg d1-d14 for 4 cycles,every 21 days for 1 cycle.

Intervention Type

Drug

Intervention Name(s)

Rituximab

Intervention Description

Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

methotrexate 3.5g/m2 civ d1/cycle5-6

Primary Outcome Measure Information:

Title

overall response rate

Description

ORR is defined as the proportion of patients with a best response of CR, CRu or PR

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

Secondary Outcome Measure Information:

Title

overall response rate

Description

ORR is defined as the proportion of patients with a best response of CR, CRu or PR

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

Title

complete response rate

Description

CR is defined as the proportion of patients with a best response of CR or CRu

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

Title

2 years progression-free survival

Description

2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing

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

Title

2 years overall survival

Description

2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive

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

Title

The occurrence of adverse events and serious adverse events

Description

Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.

Time Frame

during follow-up, up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Zhang, M.D.

Phone

+8613810000485

zhangyan10659@pumch.cn

Facility Information:

Facility Name

Beijing TianTan Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100070

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Song Lin

Phone

+86138 0112 7691

linsong2005@126.com

First Name & Middle Initial & Last Name & Degree

Song Lin

Facility Name

Sanbo Brain Hospital Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100500

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shouwei Li

Phone

+86150 1133 9604

lishouwei@ccmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Shouwei Li

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yan Zhang, M.D.

Phone

+8613810000485

zhangyan10659@pumch.cn

First Name & Middle Initial & Last Name & Degree

Daobin Zhou

12. IPD Sharing Statement

Learn more about this trial

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

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