NCT05040555 R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
| NCT ID | NCT05040555 |
| Status | Recruiting |
| Phase | — |
| Sponsor | oubai, MD/PhD |
| Condition | Diffuse Large B Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2021-08-30 |
| Primary Completion | 2023-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2021-08-30 with a primary completion date of 2023-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A single-center, prospective clinical study to evaluate the efficacy and safety of R-CDOP (Rituximab, Cyclophosphamide, Doxorubicin hydrochloride liposome, Vindesine, Prednisone ) in the treatment of newly diagnosed high tumor burden non-Hodgkin's lymphoma, which has previously shown promising efficacy.
Eligibility Criteria
Inclusion Criteria: 1. Histologically immunohistochemistry and imaging confirmed diffuse large B-cell lymphoma or follicular lymphoma grade 3B; 2. Has at least one evaluable or measurable lesion according to Lugano response criteria; 3. Patients with at least one of the following high tumor burden Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm); nodal or extranodal mass \> 7cm in its greater diameter; Hepatomegaly and splenomegaly (infiltration confirmed by PET-CT; Spleen: female \> 15cm, male \> 16cm); Pleural/peritoneal effusion; Lactate dehydrogenase (LDH) three times the upper limit of normal; PET-CT TMTV \>220cm3; 4. Patients previously untreated; 5. Patients aged over 18 and under 75 years; 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0\~2; 7. International Prognostic Index (IPI) score \> 1, or with extranodal mass diameter ≥7cm; 8. Life expectancy ≥ 6 months; 9. Left Ventricular Ejection Fraction (LVEF) ≥ 50%; 10. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule. Exclusion Criteria: 1. Pregnant or lactation and patients of childbearing age who do not want to take contraceptive measures; 2. Abnormal liver function \[total bilirubin \> 1.5 times of the upper limit of normal value; Alanine aminotransferase/Aspartate aminotransferase (ALT / AST) \> 2.5 times of upper limit of normal value for patients without liver metastasis ; ALT / AST \> 5 times of upper limit of normal value for patients with liver metastasis \], abnormal renal function (serum creatinine \> 1.5 times of upper limit of normal value) ; 3. Absolute Neutrophil Count (ANC)\<1.5×10\^9/L or Platelet (PLT)\< 75 × 10\^9/L; 4. Hypersensitivity to any study drug or its ingredients; 5. Patients with significant and uncontrolled cardiovascular disease or history; 6. Persons with mental disorders/unable to obtain informed consent; 7. Lymphoma infiltrates the central nervous system; 8. Previous history of malignant tumor; 9. HIV infection; HBV infection (HBV-DNA\> 2000 IU/ml);HCV infection (HCV-RNA\>200 IU/ml); 10. The investigator determined not suitable to participate in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05040555 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05040555 currently recruiting?
Yes, NCT05040555 is actively recruiting participants. Contact the research team at oubai16@163.com for enrollment information.
Where is the NCT05040555 trial being conducted?
This trial is being conducted at Changchun, China.
Who is sponsoring the NCT05040555 clinical trial?
NCT05040555 is sponsored by oubai, MD/PhD. The trial plans to enroll 64 participants.