Status:
RECRUITING
Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Beijing Tiantan Hospital
Capital Medical University
Conditions:
Primary Central Nervous System Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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, orela...
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). Th...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05390749
Start Date
April 11 2022
End Date
April 1 2026
Last Update
May 25 2022
Active Locations (3)
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1
Beijing TianTan Hospital
Beijing, Beijing Municipality, China, 100070
2
Sanbo Brain Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100500
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730