Compares two drug combinations for older adults with new diffuse large B-cell lymphoma
Tests adding polatuzumab vedotin to standard treatment in adults aged 70 and older with lymphoma.
Plain-language title generated from the registry record
Registry title: The Efficacy and Safety of Pola-ZR2 Versus ZR2 in the Treatment of Old Patients With de Novo Diffuse Large B-cell Lymphoma
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
Where in China
- Shanghai Institute of Hematology, Rui-Jin Hospital affiliated to Shanghai Jiao Tong University School of MedicineShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT06522555
- Record updated
- 5 August 2024
- Original description
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 lymphomaRead full original descriptionShow less
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: A Multicenter, Prospective, Randomized, Open-label, Controlled Trial
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
Inclusion: 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: History of stroke or intracranial hemorrhage within 6 months prior to start of therapy; Uncontrolled blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases; Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol; HIV-infected patients; Other medical conditions determined by the researchers that may affect the study; 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; Presence of any of the following criteria will exclude a patient from enrollment:.