Tests R-CDOP with intrathecal methotrexate in lymphoma at high risk of brain relapse

Trial details

Who runs it

Fudan University

Trial code

NCT05257018

Record updated

2 April 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: Special types of diffuse large B-cell lymphoma patients who are not suitable for induction therapy with R-CDOP, such as PMBCL, double-hit large B-cell lymphoma, etc; Clinically significant cardiac conditions, including severe cardiac insufficiency: New York Heart Association (NYHA) cardiac insufficiency class IV, unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, and Q-Tc interval greater than 500 ms; Those who had a second degree or greater operation within three weeks before treatment; Diagnosed with a malignancy other than lymphoma or under treatment, with the following exceptions:; Had received treatment with curative intent and had not developed malignancy with known active disease ≥ 5 years prior to enrollment; Basal cell carcinoma of the skin (other than melanoma) that has been adequately treated with no evidence of disease; Carcinoma in situ of the cervix that has been adequately treated with no evidence of disease; Any previous antilymphoma therapy other than short-term corticosteroids (up to 10 days); Other serious, uncontrolled concomitant conditions that may affect protocol adherence or interfere with interpretation of results include uncontrolled diabetes mellitus, or pulmonary disease (interstitial pneumonia, obstructive pulmonary disease, and a history of symptomatic bronchospasm), hypertension, and others; Patients with a known history of severe allergy to humanized or murine mAbs, or any contraindication to R-CDOP, intrathecal MTX; Those with severe active infection; HBV (HBsAg positive and HBV-DNA ≥ 104 IU / ml), HCV (HCV antibody positive and HCV-RNA measurable); And subjects with other acquired, congenital immunodeficiency diseases, including but not limited to those with HIV infection; Patients with evidence of CNS involvement (baseline cerebrospinal fluid, imaging, symptoms); Had significant coagulation abnormalities; Pregnant or lactating women.

ClinicalTrials.gov NCT05257018