DLBCL - Diffuse Large B Cell LymphomaPhase 2NCT07680933
Orelabrutinib Combined With Standard Immunochemotherapy With or Without Autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT) for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL)
A Phase 2 study testing Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT in people with DLBCL - Diffuse Large B Cell Lymphoma, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma
- What is being tested?
- Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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:
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Feng Zhu, 0516-85806985, frankfeng_2004@126.com
About this study
Official title: A Prospective, Phase II Clinical Study Protocol of Orelabrutinib Combined With Standard Immunochemotherapy With or Without Autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT) for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL)
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). The primary objective is to explore the 1-year progression-free survival (PFS) of orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT in newly diagnosed DLBCL.
Read the detailed description
Diffuse large B-cell lymphoma (DLBCL), as the most common type of adult lymphoma, accounts for 35%-40% of non-Hodgkin lymphoma (NHL) and is characterized by high heterogeneity. This study is a prospective, open-label, multicenter study in previously untreated participants with CD20-positive DLBCL. In the induction phase, patients receive 4 cycles of orelabrutinib combined with standard chemotherapy. For transplant-eligible patients, based on response assessment after 4 cycles, those achieving PR or CR proceed to auto-HSCT, followed by either 6 cycles of orelabrutinib maintenance or no maintenance based on patient preference. For transplant-ineligible patients, based on response assessment after 4 cycles, those achieving PR or CR receive an additional 2-4 cycles of orelabrutinib combination therapy. Depending on the patient's performance status, each cycle lasts 21-28 days. The primary objective is to explore the 1-year progression-free survival (PFS) of orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT in newly diagnosed DLBCL.
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Being tested
- Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT
- Keywords
- Orelabrutinib, DLBCL, auto-HSCT
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCTDrug
1+2.1 or 2.2 ±3
- Orelabrutinib: 150 mg once daily, orally, Days 1-28
2.1 Pola-R-CHP Regimen:
Polatuzumab vedotin: 1.8 mg/kg, intravenous infusion, Day 1
Rituximab: 375 mg/m², intravenous infusion, Day 1
Cyclophosphamide: 750 mg/m², intravenous administration, Day 2
Doxorubicin: 50 mg/m², intravenous administration or per institutional guidelines, Day 2
Prednisone: 100 mg/day, orally, Days 2-6
2.2. R-CHOP Regimen:
Rituximab: 375 mg/m², intravenous infusion, Day 0
Cyclophosphamide: 750 mg/m², intravenous administration, Day 1
Doxorubicin: 40-50 mg/m², intravenous administration or per institutional guidelines, Day 1
Vincristine: 1.4 mg/m², intravenous administration, Day 1 (maximum dose 2 mg) OR Vindesine: 4 mg, intravenous administration, Day 1
Prednisone: 100 mg/day, orally, Days 1-5
- auto-HSCT
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT | Experimental | In the induction phase, patients receive 4 cycles of orelabrutinib combined with standard chemotherapy. For transplant-eligible patients, based on response assessment after 4 cycles, those achieving PR or CR proceed to auto-HSCT, followed by either 6 cycles of orelabrutinib maintenance or no maintenance based on patient preference. For transplant-ineligible patients, based on response assessment after 4 cycles, those achieving PR or CR receive an additional 2-4 cycles of orelabrutinib combination therapy. Depending on the patient's performance status, each cycle lasts 21-28 days. Receives: Drug: Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year Progression free survival (PFS)
PFS is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.
Measured: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Secondary outcomes (5)
ORR (Objective Response Rate)
ORR is defined as the proportion of patients with a response of CR or PR
Measured: At the end of Consolidation therapy (up to 8 cycles, each cycle is 21-28 days )
CRR (Complete Response Rate)
CRR is defined as the proportion of patients with a best response of CR
Measured: At the end of Consolidation therapy (up to 8 cycles, each cycle is 21-28 days)
2-year Progression free survival (PFS)
PFS is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.
Measured: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2-year overall survival (OS)
Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.
Measured: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years
The occurrence of adverse events and serious adverse events
Measured: At the end of whole theray (through study completion, an average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680933
- Sponsor's protocol ID
- XYFY2026-001-01
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase II Clinical Study Protocol of 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
- Acronym / sponsor ID
- XYFY2026-001-01
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Keywords
- Orelabrutinib, DLBCL, auto-HSCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). The primary objective is to explore the 1-year progression-free survival (PFS) of orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT in newly diagnosed DLBCL.
Detailed description
Diffuse large B-cell lymphoma (DLBCL), as the most common type of adult lymphoma, accounts for 35%-40% of non-Hodgkin lymphoma (NHL) and is characterized by high heterogeneity. This study is a prospective, open-label, multicenter study in previously untreated participants with CD20-positive DLBCL. In the induction phase, patients receive 4 cycles of orelabrutinib combined with standard chemotherapy. For transplant-eligible patients, based on response assessment after 4 cycles, those achieving PR or CR proceed to auto-HSCT, followed by either 6 cycles of orelabrutinib maintenance or no maintenance based on patient preference. For transplant-ineligible patients, based on response assessment after 4 cycles, those achieving PR or CR receive an additional 2-4 cycles of orelabrutinib combination therapy. Depending on the patient's performance status, each cycle lasts 21-28 days. The primary objective is to explore the 1-year progression-free survival (PFS) of orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT in newly diagnosed DLBCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT | Experimental | Drug: Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCTIn the induction phase, patients receive 4 cycles of orelabrutinib combined with standard chemotherapy. For transplant-eligible patients, based on response assessment after 4 cycles, those achieving PR or CR proceed to auto-HSCT, followed by either 6 cycles of orelabrutinib maintenance or no maintenance based on patient preference. For transplant-ineligible patients, based on response assessment after 4 cycles, those achieving PR or CR receive an additional 2-4 cycles of orelabrutinib combination therapy. Depending on the patient's performance status, each cycle lasts 21-28 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent;
- 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);
Key exclusion criteria (10 listed)
- Presence of uncontrolled cardiovascular or cerebrovascular disease, coagulation disorders, autoimmune diseases, severe infectious diseases, etc.;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT1+2.1 or 2.2 ±3 1. Orelabrutinib: 150 mg once daily, orally, Days 1-28 2.1 Pola-R-CHP Regimen: Polatuzumab vedotin: 1.8 mg/kg, intravenous infusion, Day 1 Rituximab: 375 mg/m², intravenous infusion, Day 1 Cyclophosphamide: 750 mg/m², intravenous administration, Day 2 Doxorubicin: 50 mg/m², intravenous administration or per institutional guidelines, Day 2 Prednisone: 100 mg/day, orally, Days 2-6 2.2. R-CHOP Regimen: Rituximab: 375 mg/m², intravenous infusion, Day 0 Cyclophosphamide: 750 mg/m², intravenous administration, Day 1 Doxorubicin: 40-50 mg/m², intravenous administration or per institutional guidelines, Day 1 Vincristine: 1.4 mg/m², intravenous administration, Day 1 (maximum dose 2 mg) OR Vindesine: 4 mg, intravenous administration, Day 1 Prednisone: 100 mg/day, orally, Days 1-5 3. auto-HSCT | Drug | Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT |
Primary outcome
1 year Progression free survival (PFS)
Time frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
PFS is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.
5 secondary outcomes
ORR (Objective Response Rate)
Time frame: At the end of Consolidation therapy (up to 8 cycles, each cycle is 21-28 days )
CRR (Complete Response Rate)
Time frame: At the end of Consolidation therapy (up to 8 cycles, each cycle is 21-28 days)
2-year Progression free survival (PFS)
Time frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2-year overall survival (OS)
Time frame: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years
The occurrence of adverse events and serious adverse events
Time frame: At the end of whole theray (through study completion, an average of 1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT in people with DLBCL - Diffuse Large B Cell Lymphoma, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Zhu (0516-85806985, frankfeng_2004@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year Progression free survival (PFS) (time frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.