Actively Recruiting
The Efficacy and Safety of Pola-ZR2 Versus ZR2 in the Treatment of Old Patients With de Novo Diffuse Large B-cell Lymphoma
Led by Ruijin Hospital · Updated on 2024-08-05
100
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The Efficacy and Safety of Pola-ZR2 Versus ZR2 in the Treatment of Old Patients With de Novo Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diffuse large B-cell lymphoma without central nervous system involvement
- Age 80 years or older, or age 70-79 classified as unfit or frail by comprehensive geriatric assessment
- International prognostic index score between 2 and 5
- At least one measurable disease site with specified size criteria
- Ability to swallow capsules
- Life expectancy of at least 3 months as determined by researchers
- Written informed consent provided by patient or legal representative
- No prior use of anti-lymphoma drugs except glucocorticoids
You will not qualify if you...
- Uncontrolled blood clotting disorders, connective tissue diseases, serious infections, or other serious illnesses
- Neutrophil count below 1.5 x 10^9/L or platelet count below 80 x 10^9/L
- Liver enzymes (ALT or AST) more than twice the upper limit of normal or serum bilirubin 1.5 times higher than normal
- Creatinine above 1.5 times upper normal limit or estimated glomerular filtration rate below 40 ml/min/1.73m^2
- Significant cardiovascular diseases including low left ventricular ejection fraction, cardiomyopathies, or certain heart rhythm disorders
- Positive hepatitis B surface antigen with HBV DNA above 1.0 x 10^3 IU/ml without control
- Psychiatric disorders or inability to comply with study protocol
- HIV infection
- Stroke or intracranial hemorrhage within 6 months before therapy
- Other medical conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Institute of Hematology, Rui-Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025
Actively Recruiting
Research Team
W
Weili Zhao
CONTACT
L
Li Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here