Primary Central Nervous System Lymphoma Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | April 1, 2026 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing TianTan Hospital | Beijing | Beijing |
China | Peking Union Medical College Hospital | Beijing | Beijing |
China | Sanbo Brain Hospital Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | Beijing Tiantan Hospital, Sanbo Brain Hospital Capital Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall response rate | 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 | overall response rate | 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 | |
Secondary | complete response rate | 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 | |
Secondary | 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 | 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 | |
Secondary | 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 | From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years | |
Secondary | 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. | during follow-up, up to 2 years |
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