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

Recruiting now · Phase 2

Conditions studied: Diffuse Large B-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT05257018

Run by

Fudan University

People needed

83

Starts

2022-02-26

Expected to finish

2028-12-30

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• Patients with a known history of severe allergy to humanized or murine mAbs, or any contraindication to R-CDOP, intrathecal MTX;
• Patients with evidence of CNS involvement (baseline cerebrospinal fluid, imaging, symptoms);
• 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;
• Had significant coagulation abnormalities;
• Any previous antilymphoma therapy other than short-term corticosteroids (up to 10 days);
• Those with severe active infection;
• 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;
• 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;
• Pregnant or lactating women;

Where it is running

• Dongmei Ji — Shanghai, Shanghai Municipality, China (enrolling)
• Cancer Hospital affilicaited to Xinjiang Medical University — Ürümqi, Xinjiang, China

Full record on ClinicalTrials.gov

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