Comparing ZR2 treatment to standard chemotherapy for elderly patients with lymphoma
The Efficacy and Safety of ZR2 Versus R-CHOP-like Regimen for Elderly Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma.
This study is testing a new treatment called ZR2 to see if it works better than standard chemotherapy for older patients newly diagnosed with lymphoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Wenzhou Medical University Academic / other |
| Drugs / interventions | chemotherapy, Rituximab, Zanubrutinib |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Trial ID | NCT05428670 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a new treatment regimen called ZR2, which combines Zanubrutinib, Lenalidomide, and Rituximab, against the standard R-CHOP chemotherapy in elderly patients newly diagnosed with diffuse large B cell lymphoma. The study will assess the complete response rates, survival outcomes, and adverse reactions between the two treatment groups. Additionally, immune function tests and gene sequencing will be conducted to identify potential biomarkers for treatment efficacy. The trial aims to provide insights into the pharmacokinetics and pharmacoeconomics of the ZR2 regimen compared to traditional chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 and older with newly diagnosed diffuse large B cell lymphoma who have not received prior treatment.
Not a fit: Patients with uncontrolled cardiovascular or autoimmune diseases, those who have previously received chemotherapy, or those with significant laboratory abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective and safer treatment option for elderly patients with diffuse large B cell lymphoma.
How similar studies have performed: While there have been studies on similar treatment regimens, the specific combination of ZR2 in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed DLBCL * Without treatment * ≥ 65 years old * Measurable lesions on CT or PET-CT before treatment * Life expectancy of at least 3 months * Voluntary participation with the consent of the patient * Heart, kidney, liver and other organ function evaluation were basically normal before treatment Exclusion Criteria: * Patients who previously received chemotherapy * Uncontrolled cardiovascular diseases, cerebrovascular diseases, thrombotic diseases, autoimmune diseases and serious infectious diseases * Laboratory indicators before enrollment (unless caused by lymphoma): * Neutrophils \< 1.5 × 10\^9/L * Platelets \< 80 × 10\^9/L * Alanine aminotransferase or aspartate aminotransferase \> 2 × ULN * Alkaline phosphatase or bilirubin \> 1.5 × ULN * Creatinine \> 1.5 × ULN * Patients who cannot comply with the agreement due to mental diseases or other unknown reasons such as pregnancy and lactation * HIV infection * If HBsAg is positive, HBVDNA should be tested, and patients with positive DNA cannot be enrolled; if HBsAg is negative and HBcAb is positive (regardless of HBsAb status), HBVDNA should be tested, and patients with positive DNA cannot be enrolled * Other uncontrolled medical conditions that may interfere with the study
Where this trial is running
Wenzhou, Zhejiang
- First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Haige Ye, Ph.D
- Email: haigeye@wzhospital.cn
- Phone: +8615967413188
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.