Treatment for newly diagnosed primary central nervous system lymphoma
a Single Arm,Multi-center,Phase II Clinical Trial of Combined Therapy for Orelabrutinib,Rituximab and Methotrexate(RMO)in Newly-diagnosed Primary Center Nervous System Lymphoma(PCNSL)
PHASE2 · Affiliated Hospital to Academy of Military Medical Sciences · NCT05549284
This study is testing a new combination of treatments for people with newly diagnosed primary central nervous system lymphoma to see if it helps them respond better than current options.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Affiliated Hospital to Academy of Military Medical Sciences (other) |
| Drugs / interventions | Rituximab, Orelabrutinib, Methotrexate, chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05549284 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm, multi-center phase 2 study evaluating the efficacy and safety of a combination of Orelabrutinib, Rituximab, and high-dose Methotrexate as first-line treatment for newly diagnosed primary central nervous system lymphoma (PCNSL). The study will assess patient responses every two cycles, with those achieving complete or partial remission continuing treatment, while others will receive salvage regimens. After six cycles, patients who respond favorably may be candidates for autologous hematopoietic stem cell transplantation or alternative therapies. The primary endpoints are objective response and complete response rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed primary central nervous system diffuse large B-cell lymphoma.
Not a fit: Patients with contraindications to the treatment components or those with severe cardiac insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with newly diagnosed primary central nervous system lymphoma.
How similar studies have performed: While this approach is being evaluated in this specific context, similar combinations have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy; * Aged 18-70 years * Signature of informed consent; * At least one measurable lesion; * Neutropile≥1.5X109/L,Hemoglobin≥80g/L,Platelets≥75X109/L,Billrubin\<2XULN,ALT\<4XULN,AST4XULN * The expected survival time is at least 3 months Exclusion Criteria: * Those who have contraindications to any of the components in the Orelabrutinib,Rituximab and HD-MTX * History of other malignancies that may affect the compliance of the research protocol or the analysis of the results * Severe cardiac insufficiency * Other antitumor treatments were used * Human immunodeficiency virus(HIV)antibody is positive * Pregnant or lactating women * Researchers consider if anyone not suitable for enrollment.
Where this trial is running
Beijing, Beijing Municipality
- Hospital 307 — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: wenrong huang, Dr
- Email: huangwr301@163.com
- Phone: 861066947177
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.
Conditions: Primary Central Nervous System Lymphoma