R-CDOP Combined With Intrathecal Methotrexate for DLBCL Pati...

About this study

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.

Condition: Diffuse Large B-cell Lymphoma
Tested: R-CDOP+intrathecal MTX
Sponsor: Fudan University

Who can join

Age: 18 to 75 years
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 18

Minimum age: 18 years
Maximum age: 75 years
Study condition: Diffuse Large B-cell Lymphoma
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 15

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

2 sites, 2 recruiting

Dongmei Ji

Shanghai, Shanghai Municipality, China

Recruiting

Cancer Hospital affilicaited to Xinjiang Medical University

Ürümqi, Xinjiang, China