A Phase II Study of R-CDOP Combined With Intrathecal Methotrexate for Diffuse Large B-cell Lymphoma Patients With High-risk of Central Nervous System Relapse

Who is this study for? Patients with Diffuse Large B-cell Lymphoma
What treatments are being studied? Rituximab+Cyclophosphamide+Doxorubicin Hydrochloride+Vincristine+Prednisone+Intrathecal MTX
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Dongmei Ji
RECRUITING
Shanghai
Cancer Hospital affilicaited to Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Contact Information
Primary
Dongmei Ji, doctor
jidongmei2000@126.com
13564183928
Backup
Junning Cao, doctor
cao_junning@126.com
Time Frame
Start Date: 2022-02-26
Estimated Completion Date: 2028-01-30
Participants
Target number of participants: 83
Treatments
Experimental: R-CDOP+intrathecal MTX
R-CDOP+intrathecal MTX:~* Rituximab 375 mg / m\^2,D1~* Cyclophosphamide 750 mg / m\^2,D2~* Doxorubicin Hydrochloride Liposome Injection 35mg / m\^2,D2~* Vincristine 1.4mg/m\^2 (dose capped at 2 mg),D2~* Prednisone 50 mg, bid D2-6~* Cycle1-5:Intrathecal MTX 12 mg + DXM 5 mg after chemotherapy (PK patients will be given 24h after chemotherapy)
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov