Actively Recruiting
Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-07-18
43
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of the Pro-Pola (Pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin) regimen in elderly patients (aged ≥70 years) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
CONDITIONS
Official Title
Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years or older and unfit or frail
- Presence of at least one measurable lesion of 15 mm or more
- Histologically confirmed newly diagnosed diffuse large B-cell lymphoma (DLBCL)
- Life expectancy longer than 3 months
- Adequate organ function: cardiac ejection fraction 50% or higher; liver enzymes less than 3 times the upper limit of normal; kidney function with creatinine clearance 30 mL/min or higher; lung oxygen saturation above 90% without oxygen
- Adequate bone marrow function: hemoglobin 8 g/dL or higher; platelet count 75 x 10^9/L or higher; absolute neutrophil count 1.0 x 10^9/L or higher; if bone marrow invaded, platelet count 50 x 10^9/L or higher and neutrophil count 0.75 x 10^9/L or higher
- Ability to understand the study and provide written informed consent
- Willingness to use birth control during the study and follow-up if of childbearing potential
You will not qualify if you...
- Severe abnormal liver or kidney function (liver enzymes, bilirubin, creatinine more than 3 times the upper limit of normal)
- Organic heart disease or severe arrhythmia causing symptoms or abnormal heart function (NYHA Grade 2 or higher)
- Uncontrolled active infections
- Other tumors requiring treatment
- DLBCL involving the central nervous system
- Current or planned systemic corticosteroid treatment
- History of vascular embolism
- Psychological conditions preventing participation or consent
- Likely inability to complete study visits or follow-up as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
Z
Zhengming Jin
CONTACT
C
Changju Qu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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