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New treatment option for DLBCL - Diffuse Large B Cell Lymphoma
Official title Orelabrutinib Combined With Standard Immunochemotherapy With or Without Autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT) for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL)
ClinicalTrials.gov ID: NCT07680933
What this study is testing
What is Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT?
Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for dlbcl - 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 study is a prospective, open-label, multicenter study in previously untreated participants with CD20-positive DLBCL. Orelabrutinib combined with standard immunochemotherapy with or without autologous hematopoietic stem cell transplantation (auto-HSCT) for newly diagnosed diffuse large B-cell lymphoma (DLBCL).
- 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
- Signed informed consent;
- Age 18-80 years at the time of signing informed consent, and willingness to comply with the study protocol procedures;
- Pathologically confirmed CD20-positive DLBCL; ④ IPI score of 2-5; ⑤ ECOG performance status of 0-2; ⑥ Life expectancy ≥12 months; ⑦ Left ventricular...
- Adequate hematologic function (unless due to underlying disease, e.g., extensive bone marrow involvement, or hypersplenism secondary to splenic...
- Hemoglobin ≥90 g/L within 7 days prior to enrollment without packed red blood cell transfusion;
You likely can't join if
- Presence of uncontrolled cardiovascular or cerebrovascular disease, coagulation disorders, autoimmune diseases, severe infectious diseases, etc.;
- Abnormal laboratory values at screening (unless attributable to lymphoma):
- Coagulation function: INR \> 1.5× the upper limit of normal (ULN); PT and APTT \> 1.5× ULN;
- Liver function: ALT or AST \> 2× ULN; ALP and bilirubin \> 1.5× ULN;
- Renal function: Creatinine \> 1.5× ULN; creatinine clearance \< 60 mL/min (estimated by the Cockcroft-Gault formula); ③ HIV-infected patients; ④ For...
- Inability to swallow capsules or presence of gastrointestinal conditions that significantly affect gastrointestinal function, such as malabsorption...
See the full eligibility criteria
- Signed informed consent;
- Age 18-80 years at the time of signing informed consent, and willingness to comply with the study protocol procedures;
- Pathologically confirmed CD20-positive DLBCL; ④ IPI score of 2-5; ⑤ ECOG performance status of 0-2; ⑥ Life expectancy ≥12 months; ⑦ Left ventricular ejection fraction (LVEF) ≥50% as assessed by multigated acquisition...
- Adequate hematologic function (unless due to underlying disease, e.g., extensive bone marrow involvement, or hypersplenism secondary to splenic involvement attributed to DLBCL as determined by the investigator...
- Hemoglobin ≥90 g/L within 7 days prior to enrollment without packed red blood cell transfusion;
- Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L;
- Platelet count ≥75 × 10⁹/L. ⑨ Adequate organ function.
- Presence of uncontrolled cardiovascular or cerebrovascular disease, coagulation disorders, autoimmune diseases, severe infectious diseases, etc.;
- Abnormal laboratory values at screening (unless attributable to lymphoma):
- Coagulation function: INR \> 1.5× the upper limit of normal (ULN); PT and APTT \> 1.5× ULN;
- Liver function: ALT or AST \> 2× ULN; ALP and bilirubin \> 1.5× ULN;
- Renal function: Creatinine \> 1.5× ULN; creatinine clearance \< 60 mL/min (estimated by the Cockcroft-Gault formula); ③ HIV-infected patients; ④ For HBsAg-positive patients, HBV DNA must be negative prior to enrollment...
- Inability to swallow capsules or presence of gastrointestinal conditions that significantly affect gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, symptomatic inflammatory...
- Other concurrent and uncontrolled medical conditions that, in the investigator's opinion, may affect the patient's participation in the study, including patients with psychiatric disorders or other known or suspected...
The study team makes the final eligibility decision.
Where it's taking place
- Xuzhou, 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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xuzhou, 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.