Status:
RECRUITING
The Efficacy and Safety of Pola-ZR2 Versus ZR2 in the Treatment of Old Patients With de Novo Diffuse Large B-cell Lymphoma
Lead Sponsor:
Ruijin Hospital
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
70+ years
Phase:
PHASE3
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 (zanubru...
Detailed Description
This study will evaluate the efficacy and safety of Pola-ZR2 versus ZR2 in the treatment of elderly de novo diffuse large B-cell lymphoma patients. Subjects will be randomly assigned 1:1 to Pola-ZR2 o...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
July 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 10 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06522555
Start Date
July 29 2024
End Date
August 10 2029
Last Update
August 5 2024
Active Locations (1)
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1
Shanghai Institute of Hematology, Rui-Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025