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

NCT ID: NCT05390749

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-11
• Study Completion Date: 2026-04-01

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.

Conditions

Primary Central Nervous System Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Orelabrutinib

Intervention Type: DRUG

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

Pomalidomide

Intervention Type: DRUG

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

Rituximab

Intervention Type: DRUG

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

Methotrexate

Intervention Type: DRUG

methotrexate 3.5g/m2 civ d1/cycle5-6

Interventions

Orelabrutinib

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

Intervention Type: DRUG

Pomalidomide

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

Intervention Type: DRUG

Rituximab

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

Intervention Type: DRUG

Methotrexate

methotrexate 3.5g/m2 civ d1/cycle5-6

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

Capital Medical University

OTHER

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing TianTan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Sanbo Brain Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Zhang, M.D.

Role: CONTACT

zhangyan10659@pumch.cn

+8613810000485

Facility Contacts

Song Lin

Role: primary

linsong2005@126.com

+86138 0112 7691

Shouwei Li

Role: primary

lishouwei@ccmu.edu.cn

+86150 1133 9604

Yan Zhang, M.D.

Role: primary

zhangyan10659@pumch.cn

+8613810000485

Other Identifiers

PUMCH-NHL-013

Identifier Type: -

Identifier Source: org_study_id