Status:
RECRUITING
R-CDOP Combined With Intrathecal Methotrexate for DLBCL Patients With High-risk of CNS Relapse
Lead Sponsor:
Fudan University
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 wi...
Detailed Description
Diffuse large B-cell lymphoma is the most common subtype of non-Hodgkin's lymphoma, accounting for 31% of all non-Hodgkin's lymphomas. At present, the standard treatment is R-CHOP (rituximab, cyclopho...
Eligibility Criteria
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
- 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;
Key Trial Info
Start Date :
February 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2028
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT05257018
Start Date
February 26 2022
End Date
January 30 2028
Last Update
November 12 2024
Active Locations (2)
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1
Dongmei Ji
Shanghai, Shanghai Municipality, China, 021
2
Cancer Hospital affilicaited to Xinjiang Medical University
Ürümqi, Xinjiang, China