BridgeMD
New treatment option for Diffuse Large B-Cell Lymphoma
Official title Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL
ClinicalTrials.gov ID: NCT07072208
What this study is testing
What is Induction therapy-Pro regimen?
Induction therapy-Pro regimen 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
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join if
- Age ≥70 years unfit or frail
- There is at least one image-measurable lesion with a measurable lesion of at least 15 mm.
- Histologically confirmed treatment-naive DLBCL.
- Life expectancy is\>3 months.
- appropriate organ function: Cardiac function: Cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase...
You likely can't join if
- Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine\>3 times the upper limit of normal);
- Presence of organic heart disease or severe arrhythmia leading to clinical symptoms or abnormal cardiac function (NYHA Functional Class Grade ≥2);
- Uncontrolled active infection;
- Co-existence of other tumors requiring treatment or intervention;
- DLBCL involving central nervous system;
- Current or expected need for systemic corticosteroid treatment;
See the full eligibility criteria
- Age ≥70 years unfit or frail
- There is at least one image-measurable lesion with a measurable lesion of at least 15 mm.
- Histologically confirmed treatment-naive DLBCL.
- Life expectancy is\>3 months.
- appropriate organ function: Cardiac function: Cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: Serum creatinine...
- Adequate bone marrow reserve is defined as: Hemoglobin ≥8g/dL, platelet count ≥75×10\^9/L, Absolute neutrophil value ≥1.0×10\^9/L, If accompanied by bone marrow invasion, platelet count ≥50×10\^9/L, absolute neutrophil...
- Patients have the ability to understand and are willing to provide written informed consent.
- people with childbearing or childbearing potential must be willing to practice birth control from the date of registration in this study to the follow-up period of the study.
- Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine\>3 times the upper limit of normal);
- Presence of organic heart disease or severe arrhythmia leading to clinical symptoms or abnormal cardiac function (NYHA Functional Class Grade ≥2);
- Uncontrolled active infection;
- Co-existence of other tumors requiring treatment or intervention;
- DLBCL involving central nervous system;
- Current or expected need for systemic corticosteroid treatment;
- Previous or current history of vascular embolism;
- Other psychological conditions that prevent the patient from participating in the study or signing informed consent.
- In the investigator's judgment, it is unlikely that the subject will complete all protocol-required study visits or procedures, including follow-up visits, or will not meet the requirements for participation in the...
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, 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, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, 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.