Primary Central Nervous System Lymphoma
Conditions
Brief summary
This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in elderly patients with primary central nervous system lymphoma (PCNSL).
Detailed description
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in elderly patients with primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.
Interventions
R-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2); methotrexate 1.5 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 20mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week.
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 year Overall survival | 3 year Overall survival |
Countries
China
Contacts
Primary ContactLiren Qian, M.D.
Outcome results
None listed