Comparing ZR2 and R-miniCHOP for treating elderly patients with lymphoma
The Efficacy and Safety of Zanubrutinib, Rituximab and Lenalidomide (ZR2) Versus Rituximab Combined With Low-dose CHOP (R-miniCHOP) in the Treatment of Unfit or Frail de Novo Diffuse Large B-cell Lymphoma Patients Aged Older Than or Equal to 70 Years: A Multicenter, Prospective, Randomized, Open-label, Controlled Trial
This study is testing whether a new combination treatment for lymphoma works better than a standard treatment in older patients who are not strong enough for more aggressive therapies.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | rituximab, zanubrutinib, cyclophosphamide, doxorubicin, prednisone |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05179733 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a treatment regimen combining zanubrutinib, rituximab, and lenalidomide (ZR2) against a standard regimen of rituximab with low-dose CHOP (R-miniCHOP) in elderly patients aged 70 and older who are unfit or frail. Participants will be randomly assigned to one of the two treatment groups and will receive their respective therapies over six cycles. The study aims to determine which treatment is more effective for this vulnerable population suffering from diffuse large B-cell lymphoma.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 70 years and older with histologically-confirmed diffuse large B-cell lymphoma who are classified as unfit or frail.
Not a fit: Patients with central nervous system involvement or those who have previously received anti-lymphoma drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for elderly patients with diffuse large B-cell lymphoma who are unfit for standard therapies.
How similar studies have performed: Other studies have explored treatments for elderly lymphoma patients, but this specific combination of therapies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Patients must satisfy all of the following criteria to be enrolled in the study: * Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement) * Eastern Cooperative Oncology Group performance status 0-3 * Aged ≥ 80 years old or aged 70-79 with comprehensive geriatric assessment stratified as unfit or frail * International normalized ratio and activated partial thromboplastin time are both 1.5 times lower than the upper limits of normal (ULN). * At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters) * Life expectancy of at least 3 months determined by researchers * The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research. * Anti-lymphoma drugs have not been used before (except glucocorticoids). Exclusion criteria Presence of any of the following criteria will exclude a patient from enrollment: * Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases * Laboratory measures meet the following criteria at screening (unless caused by lymphoma): 1. Neutrophils\<1.5×10\^9/L 2. Platelets\<80×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement) 3. ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN. 4. Creatinine is 1.5 times higher than the ULN or eGFR is lower than 40ml/min/1.73m\^2 (according to Cockcroft-Gault Equation or MDRD Equation). * HIV-infected patients * Left ventricular ejection fraction\<50% * Patients with HbsAg positive are required to have HBV DNA\<1.0×10\^3 IU/ml before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA\<1.0×10\^3 IU/ml is required before entering the group. * Other anti-tumor treatments (lymphoma or other types of tumors) are currently in progress. * Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol * Require treatment with strong/moderate CYP3A inhibitors or inducers. * History of stroke or intracranial hemorrhage within 6 months prior to start of therapy * Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction * Other medical conditions determined by the researchers that may affect the study
Where this trial is running
Shanghai, Shanghai
- Ruijin Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Weili ZHAO
- Email: zwl_trial@163.com
- Phone: +862164370045
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.