Can a new drug combo boost remission in aggressive lymphoma?

NCT ID NCT07778212

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • the First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, China

  • the First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, China

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