Can a new drug combo boost remission in aggressive lymphoma?
NCT ID NCT07778212
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This trial tests whether adding orelabrutinib to a standard chemotherapy regimen (Pola-R-CHP) can improve outcomes for people with intermediate- to high-risk diffuse large B-cell lymphoma (DLBCL) who have not yet received treatment. The study will enroll about 30 adults with confirmed DLBCL and measure how many achieve complete remission, how long they live without the disease progressing, and overall survival. The goal is to see if this combination is a more effective first-line option for this aggressive cancer.
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 polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP)
- What this could lead to
- If successful, this combination could become a more effective first-line treatment for aggressive DLBCL, potentially improving remission rates and long-term survival.
- What could go wrong
- This is a small, early-stage study (30 people) without a comparison group, so results may not be definitive. The drug combo may cause significant side effects, and not all patients may benefit.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- 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 years and older
- 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: 1. Aged ≥ 18 years; 2. Pathologically confirmed diffuse large B-cell lymphoma (DLBCL) by tumor tissue, with at least one measurable lesion, including DLBCL, not otherwise specified (GCB and non-GCB subtypes), DLBCL with MYC and BCL-2 rearrangements, and high-grade B-cell lymphoma; 3. No prior receipt of other anti-tumor treatments; 4. ECOG performance status 0-2; 5. IPI score 2-5, and patients with stage III-IV disease; 6. Life expectancy ≥ 6 months; 7. Voluntarily sign a written informed consent form. Exclusion Criteria: 1. Lymphoma involving the central nervous system or leptomeningeal metastasis; 2. Transformed lymphoma, i.e., transformed from other types of lymphoma, such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, or small B-cell lymphoma; 3. Primary mediastinal large B-cell lymphoma; 4. Burkitt lymphoma; 5. Left ventricular ejection fraction \< 50%; 6. Laboratory test values at screening: (unless caused by lymphoma); 1. Neutrophils \< 1.5×10⁹/L; 2. Platelets \< 75×10⁹/L; 3. ALT or AST higher than 2 times the upper limit of normal, AKP and bilirubin higher than 1.5 times the upper limit of normal; 4. Creatinine level higher than 1.5 times the upper limit of normal; 7. Patients with psychiatric disorders or other patients who are known or suspected to be unable to fully comply with the study protocol; 8. Pregnant or lactating women; 9. Known infection with human immunodeficiency virus (HIV), or active hepatitis B or C virus infection (positive result by polymerase chain reaction \[PCR\]). If a patient has a positive HBsAg test result, HBV DNA testing is required. If HBV DNA \< 10³ IU/ml, the patient can be enrolled. If the HBsAg test result is negative, but the HBcAb test is positive (regardless of HBsAb status), HBV DNA testing is also required. If HBV DNA \< 10³ IU/ml, the patient can be enrolled. If a patient is HCV antibody positive, HCV RNA is detected by PCR technology, and a positive result meets the exclusion criterion; 10. Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers; 11. nability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction; 12. Other concurrent and uncontrolled medical conditions that the investigator deems will affect the patient's participation in the study.
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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
2 sites. 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 First Affiliated Hospital of Xiamen University
RECRUITINGXiamen, Fujian, China
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the First Affiliated Hospital of Xiamen University
RECRUITINGXiamen, Fujian, China
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