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Tests treatment safety and results for Large B-Cell Lymphoma (LBCL)
Official title The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL
ClinicalTrials.gov ID: NCT07514169
What this study is testing
What is Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen?
Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for large b-cell lymphoma (lbcl).
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 is a prospective, single-center, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen in older treatment-naive patients with large B-cell lymphoma.
- 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 70 and older
You may be able to join if
- Patients must satisfy all of the following criteria to be enrolled in the study:
- Histologically-confirmed large B-cell lymphoma (without central nervous system involvement)
- Aged ≥ 70 years old with comprehensive geriatric assessment stratified as unfit or frail, or those who decline immunochemotherapy.
- Eastern Cooperative Oncology Group Performance Status 0-2
- 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...
You likely can't join if
- 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\<1.0×10\^9/L Platelets\<75×10\^9/L ALT or AST...
- uncontrollable or significant cardiovascular diseases, including but not limited to: Left ventricular ejection fraction\ 470ms (females) or 480ms...
- 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...
- Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
See the full eligibility criteria
- Patients must satisfy all of the following criteria to be enrolled in the study:
- Histologically-confirmed large B-cell lymphoma (without central nervous system involvement)
- Aged ≥ 70 years old with comprehensive geriatric assessment stratified as unfit or frail, or those who decline immunochemotherapy.
- Eastern Cooperative Oncology Group Performance Status 0-2
- 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...
- 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)
- 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\<1.0×10\^9/L Platelets\<75×10\^9/L ALT or AST is 2.5 times higher than the upper limits of normal (ULN), serum...
- uncontrollable or significant cardiovascular diseases, including but not limited to: Left ventricular ejection fraction\ 470ms (females) or 480ms (males), type 2 second-degree atrioventricular block or third-degree...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 Shanghai, 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.