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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 (Jun 2026). This Phase 2 trial studies R-CDOP+intrathecal MTX for diffuse large b-cell lymphoma.

Phase 2RecruitingFudan UniversityNCT05257018Data as of Jun 2026Location: China

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

Treatments studied

Other

R-CDOP+intrathecal MTX

Cancer type

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Performance status

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

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT05257018 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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