Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL
- Conditions
- Primary Central Nervous System Lymphoma
- Interventions
- Registration Number
- NCT05390749
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
-
• 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
-
• 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description POR-ROMTX Orelabrutinib 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). POR-ROMTX Pomalidomide 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). POR-ROMTX Rituximab 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). POR-ROMTX Methotrexate 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).
- Primary Outcome Measures
Name Time Method overall response rate 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
- Secondary Outcome Measures
Name Time Method overall response rate 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
complete response rate 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
2 years progression-free survival 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
2 years overall survival 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
The occurrence of adverse events and serious adverse events during follow-up, up to 2 years Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
Trial Locations
- Locations (3)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Sanbo Brain Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing TianTan Hospital
🇨🇳Beijing, Beijing, China