Sequential treatment for newly diagnosed primary central nervous system lymphoma
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 study is testing a new treatment plan for people with newly diagnosed primary central nervous system lymphoma to see if a combination of medications can help them live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | rituximab, orelabrutinib, methotrexate |
| Locations | 3 sites (Beijing, Beijing and 2 other locations) |
| Trial ID | NCT05390749 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective phase II study aims to evaluate the safety and efficacy of a sequential treatment regimen involving RO-MTX after a combination of pomalidomide, orelabrutinib, and rituximab (POR) in patients with newly diagnosed primary central nervous system lymphoma (PCNSL). The study consists of two steps: first, patients will receive four cycles of the POR regimen, followed by a response evaluation. Those who achieve a partial response or better will then receive two cycles of RO-MTX. The study will monitor overall survival and treatment outcomes over a three-year period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 with newly diagnosed B-cell primary central nervous system lymphoma and adequate organ function.
Not a fit: Patients with T-cell lymphoma, systemic lymphoma involving the CNS, or those with uncontrolled infections or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could provide a chemo-free option for patients with primary central nervous system lymphoma, potentially improving their quality of life and treatment outcomes.
How similar studies have performed: While this approach is novel in the context of PCNSL, similar studies exploring chemo-free therapies have shown promise in other hematological malignancies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing and 2 other locations
- Beijing TianTan Hospital — Beijing, Beijing, China (Recruiting)
- Sanbo Brain Hospital Capital Medical University — Beijing, Beijing, China (Recruiting)
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Yan Zhang, M.D.
- Email: zhangyan10659@pumch.cn
- Phone: +8613810000485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.