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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma

A Prospective, Single-Arm, Multicenter Clinical Study of Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma

Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma (NCT07078500) is a Phase 2 interventional studying Diffuse Large B-Cell Lymphoma (DLBCL), sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Diffuse Large B-Cell Lymphoma (DLBCL) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 48 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age 18 to 80 years old. 2. Diffuse large B-cell lymphoma (DLBCL) confirmed by tumor tissue pathology, with at least one measurable lesion. 3. Non-GCB. 4. No prior anti-tumor treatment. 5. ECOG score of 0-2. 6. Life expectancy of ≥6 months. 7. Voluntary written willing to sign a consent form. Who Should NOT Join This Trial: 1. Lymphoma involving the central nervous system or leptomeningeal metastasis. 2. 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. 3. Primary mediastinal large B-cell lymphoma. 4. Burkitt lymphoma. 5. Laboratory values at screening (unless due to lymphoma): 1. Neutrophils \<1.5×10⁹/L; 2. Platelets \<75×10⁹/L; 3. 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; 4. Creatinine level more than 1.5 times the upper limit of normal. 6. Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol. 7. Pregnant or breastfeeding women. 8. Known human weakened immune system 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. If HBV DNA \<10³ IU/ml, the patient may be enrolled. If the patient tests negative for HbsAg but positive for HBcAb (regardless of HBsAb status), HBV DNA testing is also required. If HBV DNA \<10³ IU/ml, the patient may be enrolled. If the patient tests positive for HCV antibody, HCV RNA is detected by PCR. If positive, the patient meets the exclusion criteria. 9. Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age 18 to 80 years old. 2. Diffuse large B-cell lymphoma (DLBCL) confirmed by tumor tissue pathology, with at least one measurable lesion. 3. Non-GCB. 4. No prior anti-tumor treatment. 5. ECOG score of 0-2. 6. Life expectancy of ≥6 months. 7. Voluntary written informed consent. Exclusion Criteria: 1. Lymphoma involving the central nervous system or leptomeningeal metastasis. 2. 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. 3. Primary mediastinal large B-cell lymphoma. 4. Burkitt lymphoma. 5. Laboratory values at screening (unless due to lymphoma): 1. Neutrophils \<1.5×10⁹/L; 2. Platelets \<75×10⁹/L; 3. 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; 4. Creatinine level more than 1.5 times the upper limit of normal. 6. Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol. 7. Pregnant or breastfeeding women. 8. 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. If HBV DNA \<10³ IU/ml, the patient may be enrolled. If the patient tests negative for HbsAg but positive for HBcAb (regardless of HBsAb status), HBV DNA testing is also required. If HBV DNA \<10³ IU/ml, the patient may be enrolled. If the patient tests positive for HCV antibody, HCV RNA is detected by PCR. If positive, the patient meets the exclusion criteria. 9. Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers. 10. Inability to swallow capsules or significant gastrointestinal disorders, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction. 11. Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.

Treatments Being Tested

DRUG

orelabrutinib combined with the Pola-R-CHP regimen

Enrolled patients will receive six cycles of orelabrutinib in combination with the Pola-R-CHP regimen, with each 21-day period being one cycle. At the end of the six cycles, an interim efficacy evaluation will be conducted. Patients with a response of CR or PR will receive an additional two cycles of orelabrutinib in combination with rituximab and undergo a final efficacy evaluation. Patients with a response of CR/PR after eight cycles of induction therapy will receive maintenance treatment with orelabrutinib for up to two years.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07078500), the sponsor (Second Affiliated Hospital, School of Medicine, Zhejiang University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07078500 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07078500?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07078500?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT07078500. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07078500. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.