Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: R-IDARAM plus intrathecal chemotherapy.
- Who it may be relevant to
- Registry conditions: Primary Central Nervous System Lymphoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treatment of Primary CNS Lymphoma With Systemic R-IDARAM Chemotherapy and Intrathecal Immunochemotherapy
Overview
This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in primary central nervous system lymphoma (PCNSL) patients.
Detailed description
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.
Interventions
- Drug R-IDARAM plus intrathecal chemotherapy
R-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2 and 3); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2 and 3); methotrexate 2 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 10mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week.
Primary outcome measures
- Overall survival [Time frame: 3 year Overall survival]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Navy General Hospital — Beijing
Identifiers
NCT: NCT02657785 · NavyGHB-001 · 001