New drug cocktail aims to outsmart aggressive blood cancer
NCT ID NCT07680933
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This phase 2 trial tests whether adding the targeted drug orelabrutinib to standard chemotherapy, with or without a stem cell transplant, can improve outcomes for people newly diagnosed with an aggressive type of non-Hodgkin lymphoma called DLBCL. The study enrolls 30 adults aged 18-80 with CD20-positive DLBCL and an IPI score of 2-5. The main goal is to see how many participants remain cancer-free one year after starting treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Orelabrutinib combined with standard immunochemotherapy (Pola-R-CHP or R-CHOP) with or without autologous hematopoietic stem cell transplantation
- What this could lead to
- If successful, this combination could offer a more effective first-line treatment for aggressive DLBCL, potentially improving long-term disease control and reducing relapse risk.
- What could go wrong
- This is a small, early-phase (phase 2) study with only 30 participants, so results may not apply broadly. Adding orelabrutinib to chemotherapy increases the risk of side effects like infections, bleeding, and organ toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 (MUGA) scan or echocardiography (ECHO); * 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; transfusion of blood products is permitted), defined as follows: 1. Hemoglobin ≥90 g/L within 7 days prior to enrollment without packed red blood cell transfusion; 2. Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L; 3. Platelet count ≥75 × 10⁹/L. ⑨ Adequate organ function. Exclusion Criteria: * Presence of uncontrolled cardiovascular or cerebrovascular disease, coagulation disorders, autoimmune diseases, severe infectious diseases, etc.; * Abnormal laboratory values at screening (unless attributable to lymphoma): 1. Coagulation function: INR \> 1.5× the upper limit of normal (ULN); PT and APTT \> 1.5× ULN; 2. Liver function: ALT or AST \> 2× ULN; ALP and bilirubin \> 1.5× ULN; 3. 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. In addition, if a patient is HBsAg-negative but HBcAb-positive (regardless of HBsAb status), HBV DNA testing is still required. If the result is positive, antiviral therapy is needed, and HBV DNA must be negative prior to enrollment; ⑤ Requiring continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers. Patients who have taken strong or moderate CYP3A inhibitors or CYP3A inducers within 7 days prior to the first dose of study drug (or have not completed at least 5 half-lives since the last dose) are not eligible for 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 bowel disease, or partial or complete intestinal obstruction; * 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 inability to fully comply with the study protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Affiliated Hospital of Xuzhou Medical University
RECRUITINGXuzhou, Jiangsu, 221000, China
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