Treatment for primary central nervous system lymphoma using R-IDARAM and intrathecal chemotherapy
Treatment of Primary CNS Lymphoma With Systemic R-IDARAM Chemotherapy and Intrathecal Immunochemotherapy
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 |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Navy General Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT02657785 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with other involved sites, significant comorbidities, or previous malignancies 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 patients with primary central nervous system lymphoma.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating PCNSL with combined therapies, indicating potential for success.
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.