Treatment for primary central nervous system lymphoma using R-IDARAM and intrathecal chemotherapy
Official title: Treatment of Primary CNS Lymphoma With Systemic R-IDARAM Chemotherapy and Intrathecal Immunochemotherapy
Run by Navy General Hospital, Beijing · NCT02657785 · Data updated 2026-11-12
This study tests a new treatment combining R-IDARAM and intrathecal chemotherapy to see if it helps people with primary central nervous system lymphoma feel better and live longer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Navy General Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | September 2010 |
| Main results expected | December 2028 |
| Study ends | December 2030 |
| Registry record updated | September 9, 2020 |
| Trial ID | NCT02657785 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with newly diagnosed, histologically proven non-Hodgkin's lymphoma localized to the brain, meninges, CSF, or eyes.
✕Probably not a fit
Patients with other involved sites, significant comorbidities, or previous malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of R-IDARAM combined with intrathecal immunochemotherapy in patients with primary central nervous system lymphoma (PCNSL). The study aims to assess response rates, progression-free survival, overall survival, and toxicity associated with this treatment approach. Participants will receive systemic and intrathecal chemotherapy, with radiotherapy deferred to a later stage if necessary. The trial is designed to provide insights into the potential benefits of this combined treatment strategy for PCNSL.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with primary central nervous system lymphoma.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in treating PCNSL with combined therapies, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL). Exclusion criteria: * Involved sites other than the brain, meninges, CSF, or the eyes. * Age less than 18 years or greater than 75 years. * Inadequate bone marrow capacity (defined as neutrophils\<1.5 ×10\^9/L, platelets \<100 ×10\^9/L, and hemoglobin level\< 8 g/dL). * Known cause of immunosuppression (ie, HIV type I infection). * Any previous malignancy. * Creatinine clearance below 60 mL/min. * Heart insufficiency (NYHA IIIB or IV). * Uncontrolled infection. * Noncompensated active pulmonary or liver disease. * Previously treated for PCNSL, except by corticosteroids.
Where it's running
-
Navy General Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Liren Qian, M.D.
- Email: qlr2007@126.com
- Phone: +861066957676
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Rapid CSF ctDNA Test and Treatment Monitoring for Primary CNS Lymphoma
This study tests whether CSF circulating tumor DNA can quickly diagnose primary CNS lymphoma and monitor response to treatment in adults.
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Testing a four-drug regimen (methotrexate, rituximab, sintilimab, pirtobrutinib) versus investigator-selected care for newly diagnosed PCNSL
This trial will try a combination of methotrexate, rituximab, sintilimab and pirtobrutinib as first treatment for adults with newly diagnosed primary central nervous system lymphoma to see if it increases complete remissions and is safe compared with standard doctor-selected treatments.
-
Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL
In this study, adults with newly diagnosed primary CNS lymphoma try different induction regimens to see which one works best before consolidation therapy.
-
Epcoritamab plus ibrutinib for central nervous system lymphoma
This trial tests whether combining epcoritamab and ibrutinib is safe and tolerable for adults with relapsed or refractory primary or secondary central nervous system lymphoma.
-
Tirabrutinib maintenance therapy for patients with primary CNS lymphoma in remission
This study is testing if taking tirabrutinib every day can help people with primary CNS lymphoma stay in remission longer after their initial treatment.
-
Glofitamab after obinutuzumab pre-treatment for central nervous system lymphoma
This trial will test if giving glofitamab after a short obinutuzumab pre-treatment is safe and helpful for adults with primary or secondary central nervous system lymphoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.