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New treatment option for Diffuse Large B Cell Lymphoma
Official title Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients with Treatment-naive Non-GCB DLBCL
ClinicalTrials.gov ID: NCT06530511
What this study is testing
What is Polatuzumab vedotin?
Polatuzumab vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse large b cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly patients with Non-GCB DLBCL. This study is to evaluate the preliminary efficacy and safety of the combination of Polatuzumab, Rituximab, and orelabrutinib in this population.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Patients with histopathologically confirmed DLBCL;
- The sGA evaluation result of octogenarians or 60-79 years old is unfit or f RA il;
- Non-germinal center (Non-GCB) type;
- ECOG performance status score of 0-3 points; ⑤ No previous treatment for Lymphoma (unless glucocorticoid); 6 Radiographic Investigation to measurable...
- Life expectancy ≥ 12 weeks; ⑨ Signed written informed consent.
You likely can't join if
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, Coagulopathy diseases, autoimmune diseases and severe Immunization diseases...
- Laboratory abnormalities at screening (unless caused by Lymphoma) A) ANC \< 1.5 x 109/L, PLT \< 80 x 109/L b） Coagulation: INR greater than 1.5 x...
- HbsAg positive patients should be HBV DNA negative before enrollment; in addition, if the patients are HBsAg negative but HBcAb positive (regardless...
- Requires continuous treatment with strong and moderate CYP3A inhibitors or CYP3A Induction agents. Patients who have taken strong and moderate CYP3A...
The study team makes the final eligibility decision.
Where it's taking place
- Nantong, Jiangsu, China
- Nanjing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantong, Jiangsu, China; Nanjing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.