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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2028
  • participants needed
    83
  • sponsor
    Fudan University
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Updated on 4 October 2022
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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.

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, cyclophosphamide, doxorubicin, vincristine, prednisone) Regimen. In DLBCL, central nervous system recurrence is rare, but once it occurs, it is often fatal. The prognosis of patients with central recurrence of DLBCL is very poor, and the median survival time is only 3.5-7 months.The CNS relapse rate of the R-CHOP regimen combined with MTX (methotrexate) intrathecal in high CNS-IPI DLBCL patients is approximately 12%.

This study was a phase II, prospective, single arm，double-center study, which requires a total of 83 DLBCL patients with high-risk of CNS relapse.

Patients will receive a total of 6-8 cycles of R-CDOP regimen, repeated every 3 weeks. Intrathecal MTX will be administered after the 1st-5th cycle of chemotherapy. All the patients will receive a mid-treatment PET scan after 4 cycles of chemotherapy. Patient achieves CR (complete response) after 4 cycles will continue to receive another 2 cycles of treatment. For those who achieve PR, another 4 cycles of chemotherapy will given.

Details
Condition Diffuse Large B-cell Lymphoma
Treatment R-CDOP+intrathecal MTX
Clinical Study IdentifierNCT05257018
SponsorFudan University
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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
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 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
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
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