Using intravenous methotrexate to prevent CNS relapse in high-risk DLBCL patients
Intravenous Methotrexate 1g/m2 as Central Nervous System Prophylaxis for High Risk Diffuse Large B Cell Lymphoma: a Prospective, Phase III, Randomized, Controlled Study
This study is testing if giving high-risk DLBCL patients intravenous methotrexate can better prevent brain relapses compared to the usual method of giving it directly into the spine.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 488 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05054426 on ClinicalTrials.gov |
What this trial studies
This phase III, multicenter, randomized, controlled study aims to evaluate the effectiveness of intravenous methotrexate (IV MTX) at a dose of 1g/m2 compared to intrathecal methotrexate (IT MTX) in preventing central nervous system (CNS) relapse in patients with high-risk diffuse large B cell lymphoma (DLBCL). All participants will receive the RCHOP regimen as their front-line treatment. The study will assess the two-year CNS relapse rate as the primary endpoint, along with progression-free survival (PFS), overall survival (OS), and safety as secondary endpoints. The goal is to confirm the efficacy of IV MTX based on previous findings that suggested a significant reduction in CNS relapse rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with high CNS risk DLBCL who are planned to receive RCHOP treatment and have no CNS involvement at diagnosis.
Not a fit: Patients with primary CNS lymphoma, existing CNS involvement at diagnosis, or other specific high-grade lymphomas will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of CNS relapse in high-risk DLBCL patients, improving their overall prognosis.
How similar studies have performed: Previous studies have shown promising results with intravenous methotrexate in reducing CNS relapse rates, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age ≥ 18 years * with high CNS risk, which was defined as involvement of more than one extranodal site, or involvement of particular extranodal sites such as bone marrow, breasts, testes, paranasal sinuses, epidural space, adrenal glands, kidney and female genital system; * first-line treatment planned to be RCHOP * absence of CNS involvement at presentation Exclusion Criteria: * primary CNS lymphoma * already have CNS involvement at diagnosis * primary mediastinal lymphoma, intravascular large B-cell lymphoma, DLBCL leg-type, Burkitt lymphoma, high-grade lymphomas, double expressor lymphoma * with active infection or other malignancy * severe liver or kidney insufficiency * allergy to any medication we plan to use
Where this trial is running
Beijing, Beijing
- Peking union medical college hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Wei Wang, MD.
- Email: wangweipumc@163.com
- Phone: 8613810131294
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.