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OncoMatch/Clinical Trials/NCT05257018

R-CDOP Combined With Intrathecal Methotrexate for DLBCL Patients With High-risk of CNS Relapse

Is NCT05257018 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies R-CDOP+intrathecal MTX for diffuse large b-cell lymphoma.

Phase 2RecruitingFudan UniversityNCT05257018Data as of May 2026

Treatment: R-CDOP+intrathecal MTXThis 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.

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Extracted eligibility criteria

Cancer type

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: antilymphoma therapy

Exception: short-term corticosteroids (up to 10 days)

Lab requirements

Blood counts

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

Kidney function

Cr < 1.5×UNL and creatinine clearance≥30 ml/min

Liver function

total bilirubin, ALT, AST < 1.5×UNL (upper limit of normal)

Cardiac function

Echocardiography or nuclide cardiac function testing with LVEF≥50%

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%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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