A Phase II Study of R-CDOP Combined With Intrathecal Methotrexate for Diffuse Large B-cell Lymphoma Patients With High-risk of Central Nervous System Relapse
This is a double-center, single-arm, phase 2 study to evaluate the efficacy and safety of R-CDOP regimen combined with intrathecal methotrexate in chemo-naive diffuse large B-cell lymphoma patients with high-risk of CNS relapse.
• Age range from 18 to 75 years;
• ECOG performance status: 0-2;
• Histopathologically confirmed untreated diffuse large B-cell lymphoma (cell origin can be distinguished according to Hans algorithm) , And fulfilled the following criteria for high-risk CNS recurrence:
∙ CNS-IPI 4-6;
‣ The lymphoma involved testis, breast (excluding unilateral breast and less than 5 cm mass), adrenal gland, kidney, paranasal sinus, paravertebral, and bone marrow and other sites;
‣ PCLBCL-leg;
• Subjects have at least one measurable lesion: the long axis of the lymph node shall be\>1.5 cm, the long axis of the extranodal lesions shall be\>1.0 cm;
• Bone marrow hematopoiesis was essentially normal: WBC≥3.5 ×10\^9/L, ANC≥1.5×10\^9/L, PLT≥80×10\^9/L, Hb≥90 g/L. Abnormal peripheral blood indices, as a result of lymphoma invading the bone marrow or spleen, permitted enrollment at the discretion of the investigator;
• Liver function: total bilirubin, ALT, AST \< 1.5×UNL (upper limit of normal);
• Renal function: Cr \< 1.5×UNL and creatinine clearance≥30 ml/min;
• Echocardiography or nuclide cardiac function testing with LVEF≥50%;
• Patients in the reproductive period agreed to appropriate contraception. Women in the reproductive period had a negative serum pregnancy test within 2 weeks before enrollment;
⁃ Consent to provide pathological tissue specimens (wax blocks within half a year or 20 slides for paraffin tissue sections);
⁃ Life expectancy≥3 months;
⁃ Signed informed consent;