Randomized phase III study of Rituximab with intensified CHOP chemotherapy (R-iCHOP-14) versus Rituximab with High-DoseSequential Therapy and Autologous Stem Cell Transplantation (R-HDT+ASCT) in Adult Patients (18-65 yrs) with Stage II-IVHigh-intermediate or High Risk Diffuse Large B-Cell Lymphoma.

未提供0 个研究点目标入组 250 人开始时间: 待定最近更新: 2024年2月28日

试验速览

•1. Patients with a confirmed histologic diagnosis of DLBCL according to the WHO classification;
•2. Ann Arbor stage II-IV;
•3. High-intermediate or high risk NHL according to age-adjusted IPI score (aa IPI=2-3);
•4. DLBCL must be CD20 positive;
•5. Age 18-65 years inclusive;
•6. WHO performance status <= 2;
•7. Negative pregnancy test (if applicable);
•8. Written informed consent.

•1. Intolerance of exogenous protein administration;
•2. Severe cardiac dysfunction (NYHA classification II-IV,
•Appendix F) or LVEF < 45 %;
•3. Significant renal dysfunction (serum creatinine >= 150
•mumol/l), unless related to NHL;
•4. Significant hepatic dysfunction (total bilirubin >= 30 mumol/l or
•transaminases >= 2.5 times normal level), unless related to NHL;
•5. Suspected or documented Central Nervous System involvement by NHL;
•6. Testicular DLBCL;
•7. Primary mediastinal B cell lymphoma;
•8. Patients known to be HIV-positive;
•9. Patients with active, uncontrolled infections;
•10. Patients with uncontrolled asthma or allergy, requiring steroid treatment;
•11. Patient is a lactating woman;
•12. Unwillingness or not capable to use effective means of anticonception (all men and pre-menopausal women);
•13. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of
•prednisone (< 1 wk) and/or cyclophosphamide (< 1 wk and not
•in excess of 900 mg/m2 cumulative) or local radiotherapy in order to control life threatening tumor related symptoms;
•14. History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma.

发起方

未提供