Treatment for elderly patients with primary central nervous system lymphoma
Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With Primary CNS Lymphoma
This study is testing a new treatment for older patients with primary central nervous system lymphoma to see if it helps them live longer and feel better without using radiation right away.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 60 Years to 75 Years |
| Sex | All |
| Sponsor | Navy General Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT02836158 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of R-IDARAM combined with intrathecal immunochemotherapy in elderly patients diagnosed with primary central nervous system lymphoma (PCNSL). The investigators will assess various outcomes including response rate, progression-free survival, overall survival, and toxicity associated with the treatment. The approach involves administering systemic and intrathecal immunochemotherapy while deferring radiotherapy to optimize patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 18 to 75 with newly diagnosed histologically proven non-Hodgkin's lymphoma affecting the central nervous system.
Not a fit: Patients with other involved sites of lymphoma, significant comorbidities, or those who have previously been treated for PCNSL may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for elderly patients with PCNSL.
How similar studies have performed: While this approach is promising, it is not widely tested in similar studies, indicating a novel exploration in treatment for this patient population.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- Navy General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Liren Qian, M.D.
- Email: qlr2007@126.com
- Phone: +861066957676
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.