JCOG2201: A randomized phase III study of pola-R-CHP/High-dose methotrexate/IT vs. Pola-R-CHP/IT for diffuse large B-cell lymphoma with high risk of CNS relapse (PREMIER)
- Conditions
- Untreated diffuse large B-cell lymphoma with high risk of CNS relapse
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 390
(1) Pathologically proven mature B-cell neoplasms of the following except for histological transformation from lymphoid tumors other than diffuse large B-cell lymphoma (DLBCL). DLBCL, NOS T-cell/histiocyte-rich large B-cell lymphoma Primary cutaneous DLCBL, leg type EBV positive DLCBL, NOS ALK-positive large B-cell lymphoma (2) No diagnosis of high-grade B-cell lymphoma when FISH or chromosome testing is performed. If treatment needs to be started immediately, the patient may be registered before the test results are confirmed. (3) CD20 positive. (4) Any of the following (i) to (iii) are fulfilled. (i) CNS-IPI score of 4 to 6 (ii) CNS-IPI score of 0 to 3 with involvement of one or more of the organs at high risk of CNS relapse (iii) CNS-IPI score of 0 to 3 with no lesions of the organs at high risk of CNS relapse and 3 or more extranodal lesions. (5) Aged 18 to 79 years old (6) ECOG performance status (PS) of 0 to 2 (7) The presence or absence of measurable lesions is not required (8) No central nervous system involvement (9) No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy for DLBCL (10) No prior immunosuppressant treatment. (11) Sufficient organ function (assessed whithin 14 days prior to registration): (i) Peripheral blood tumor cell count>= 10,000/mm3 (ii) Absolute neutrophil count >= 1,000/mm3 (iii) Platelet count >= 75,000/mm3 (>= 50,000/mm3 in patients with bone marrow invasion of lymphoma) (iv) Total bilirubin <= 2.0 mg/dL (v) AST <=100 U/L (vi) ALT <= 100 U/L (vii) Serum creatinine <= 1.5 mg/dL (vii) SpO2 >= 93% (room air) (12) No ischemic change, atrial fibrillation, or ventricular arrhythmias requiring treatment on the latest ECG (assessed whithin 28 days prior to registration) (13) Left ventricular ejection fraction >= 50% (assessed whithin 56 days prior to registration) (14) Written informed consent
(1) Synchronous double or multiple cancer or metachronous double or multiple cancer with progression free period less than 5 years. (2) Infectious disease requiring systemic treatment. (3) A fever over 38 degrees (except when infection or drug fever can be ruled out). (4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy. (5) Severe psychological disorder. (6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. (7) Uncontrollable diabetes mellitus. (8) Uncontrollable hypertension. (9) Unstable angina pectoris, or history of myocardial infarction within 6 months. (10) Uncontrollable valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. (11) Positive HBs antigen or HCV antibody. (12) Positive HIV antibody. (13) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema on chest X-ray.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - Progression-free survival
- Secondary Outcome Measures
Name Time Method