primary central nervous system lymphoma
Conditions
Interventions
Experiment group:high dose chemotherapy
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion Criteria: a.With no evidence of lymphoma other than the brain, spinal cord, eyes, brain nerve, and/or meningeal after a comprehensives staging examination(MRI of the head, MRI of the spinal cord, CT of the chest, abdomen and pelvis, slit lamp examination of ophthalmology, cerebrospinal fluid examination); b.Histopathologically and immunohistochemical proven diagnostic of Primary CNS diffuse large B cell lymphoma/ c.At least one objective lesion can be evaluated; d.Aged >18 and = 40; e.Expected survival time >= 2 months; f.Written informed consent; g.Untreated after diagnosis(including chemotherapy and radiotherapy); h.Neutrophils >= 1.5*10^9 / L, platelets >= 100 * 10^9 / L, hemoglobin >= 80g / L ; i.Total bilirubin is normal, transaminase less than three times the upper limit of normal, creatinine clearance rate greater than 0.83 ml / s; 2. Additional randomized grouping criteria : All participants above receive R-MAD regimen induction chemotherapy, After induction therapy, patients with complete remission (CR) or partial remission (PR) will randomly be divided into two groups for consolidation therapy. The experimental group will be treated with high-dose chemotherapy (EA group), and the control group will be treated with whole brain radiotherapy (WBRT group).
Exclusion criteria
Exclusion criteria: Exclusion Criteria: a.Previous history of any other malignant tumor or peripheral diffuse large B cell lymphoma. b.Previous history of organ transplantation or other cause of severe immunodeficiency (including HIV infection and consistence administration of immunosuppressor). c.Systemic active infections requiring treatment, including hepatitis B active infections. d.Patients with any other severe active disease or mental disease according to the judgment of the researchers. e.Patients with uncontrolled or severe cardiovascular diseases, including myocardial infarction, III-IV grade heart failure defined by the New York Heart Association ( NYHA ), uncontrolled angina, and clinically significant pericardial diseases or cardiac amyloidosis within six months before admission. f.Pregnancy or lactation period. g.Active sexual women with no contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete remission rate;partial remission rate;2-year overall survival;toxicity; | — |
Countries
China
Contacts
Public ContactYuanbo Liu
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed