NCT06522555 The Efficacy and Safety of Pola-ZR2 Versus ZR2 in the Treatment of Old Patients With de Novo Diffuse Large B-cell Lymphoma
| NCT ID | NCT06522555 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ruijin Hospital |
| Condition | Diffuse Large B-Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-29 |
| Primary Completion | 2028-08-10 |
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.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2024-07-29 with a primary completion date of 2028-08-10.
⚠ 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 multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of Pola-ZR2 (polatuzumab vedotin, zanubrutinib, rituximab and lenalidomide) versus ZR2 (zanubrutinib, rituximab and lenalidomide) in the treatment of old patients with de novo diffuse large B-cell lymphoma
Eligibility 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) * Aged ≥ 80 years old or aged 70-79 with comprehensive geriatric assessment stratified as unfit or frail * International prognostic index score 2 to 5 * 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) * Able to swallow capsules * 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 blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases * Laboratory measures meet the following criteria at screening (unless caused by lymphoma): Neutrophils\<1.5×10\^9/L Platelets\<80×10\^9/L ALT or AST is 2 times higher than the upper limits of normal (ULN), serum bilirubin are 1.5 times higher than the ULN. 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). * uncontrollable or significant cardiovascular diseases, including but not limited to: Left ventricular ejection fraction\<50% Cardiomyopathy, such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy QTc prolongation with clinical significance, QTc interval\>470ms (females) or 480ms (males), type 2 second-degree atrioventricular block or third-degree atrioventricular block * 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 * Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol * HIV-infected patients * History of stroke or intracranial hemorrhage within 6 months prior to start of therapy * Other medical conditions determined by the researchers that may affect the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06522555 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, 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.
What phase is the NCT06522555 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT06522555 currently recruiting?
Yes, NCT06522555 is actively recruiting participants. Contact the research team at zwl_trial@163.com for enrollment information.
Where is the NCT06522555 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06522555 clinical trial?
NCT06522555 is sponsored by Ruijin Hospital. The trial plans to enroll 100 participants.