R-CDOP Combined With Intrathecal Methotrexate for DLBCL Patients With High-risk of CNS Relapse (NCT05257018) | Clinical Trial Compass
RecruitingPhase 2
R-CDOP Combined With Intrathecal Methotrexate for DLBCL Patients With High-risk of CNS Relapse
China83 participantsStarted 2022-02-26
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. 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;
What they're measuring
1
2-year central nervous system relapse rate
Timeframe: up to 6 years after the start of the study
2
Concentration of doxorubicin in cerebrospinal fluid after using doxorubicin hydrochloride liposome injection
Timeframe: up to 4 years after the start of the study
✕. 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;