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New treatment option for Diffuse Large B-Cell Lymphoma (DLBCL)
Official title Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma
ClinicalTrials.gov ID: NCT07078500
What this study is testing
What is orelabrutinib combined with the Pola-R-CHP regimen?
orelabrutinib combined with the Pola-R-CHP regimen is an investigational medicine, being studied as a potential treatment for diffuse large b-cell lymphoma (dlbcl).
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
- Assess the preliminary efficacy and safety of orelabrutinib in combination with the Pola-R-CHP regimen for the treatment of treatment-naive Non-GCB diffuse 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 18 to 80
You may be able to join if
- Age 18 to 80 years old.
- Diffuse large B-cell lymphoma (DLBCL) confirmed by tumor tissue pathology, with at least one measurable lesion.
- Non-GCB.
- No prior anti-tumor treatment.
- ECOG score of 0-2.
You likely can't join if
- Lymphoma involving the central nervous system or leptomeningeal metastasis.
- Transformed lymphoma, that is, transformed from other types of lymphoma, such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic...
- Primary mediastinal large B-cell lymphoma.
- Burkitt lymphoma.
- Laboratory values at screening (unless due to lymphoma):
- Neutrophils \<1.5×10⁹/L;
See the full eligibility criteria
- Age 18 to 80 years old.
- Diffuse large B-cell lymphoma (DLBCL) confirmed by tumor tissue pathology, with at least one measurable lesion.
- Non-GCB.
- No prior anti-tumor treatment.
- ECOG score of 0-2.
- Life expectancy of ≥6 months.
- Voluntary written informed consent.
- Lymphoma involving the central nervous system or leptomeningeal metastasis.
- Transformed lymphoma, that is, transformed from other types of lymphoma, such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, or small B-cell lymphoma.
- Primary mediastinal large B-cell lymphoma.
- Burkitt lymphoma.
- Laboratory values at screening (unless due to lymphoma):
- Neutrophils \<1.5×10⁹/L;
- Platelets \<75×10⁹/L;
- ALT or AST more than 2 times the upper limit of normal, ALP and bilirubin more than 1.5 times the upper limit of normal;
- Creatinine level more than 1.5 times the upper limit of normal.
- Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol.
- Pregnant or breastfeeding women.
- Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive result by polymerase chain reaction [PCR]). If the patient tests positive for HbsAg, HBV DNA testing is required...
- Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers.
- Inability to swallow capsules or significant gastrointestinal disorders, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction.
- Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.