Treatment for newly diagnosed high tumor burden non-Hodgkin's lymphoma
A Prospective Clinical Study of R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
This study is testing a new treatment combination for people with newly diagnosed high tumor burden non-Hodgkin's lymphoma to see if it helps them feel better and stay safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Drugs / interventions | Rituximab, Cyclophosphamide, Doxorubicin, Prednisone |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT05040555 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of the R-CDOP regimen, which includes Rituximab, Cyclophosphamide, Doxorubicin hydrochloride liposome, Vindesine, and Prednisone, in patients with newly diagnosed non-Hodgkin's lymphoma characterized by high tumor burden. The study is a single-center, prospective investigation aimed at patients who meet specific criteria related to tumor size and burden. The goal is to provide a basis for the application of Doxorubicin hydrochloride liposome in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with newly diagnosed diffuse large B-cell lymphoma or follicular lymphoma grade 3B and high tumor burden.
Not a fit: Patients with low tumor burden or those who have received prior treatment for lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with high tumor burden non-Hodgkin's lymphoma.
How similar studies have performed: Other studies have shown promising efficacy with similar treatment regimens, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changchun, Jilin
- The First Bethune Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
Study contacts
- Study coordinator: Ou BAI, doctor
- Email: oubai16@163.com
- Phone: 13039046656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.