Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2NCT07499271
Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation
A Phase 2 study testing POLA-R-CHP and Orelabrutinib in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Genetic subtype-matched targeted therapy in the treatment of treatment-naive diffuse large B-cell lymphoma with TP53 mutation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma (DLBCL)
- What is being tested?
- POLA-R-CHP and Orelabrutinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and older, up to 70 years.
- Participants must be able to understand and willing to sign the written informed consent form.
- Eastern Cooperative Oncology Group performance status 0 to 3.
- Life expectancy ≥3 months (as determined by the investigator).
- Pathologically (histologically or cytologically) confirmed treatment-naive CD20-positive diffuse large B-cell lymphoma.
- Measurable disease defined by PET-CT as a short-axis diameter of at least ≥1.5 cm.
Show all 14Show fewer
- Bone marrow and organ function meeting the following criteria (without blood transfusion, G-CSF, or medication correction within 14 days prior to screening):
- Bone marrow function: Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥80×10⁹/L, hemoglobin ≥80 g/L.
- Liver function: Total serum bilirubin ≤1.5×ULN (≤3.0×ULN if liver metastases present); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (≤5.0×ULN if liver metastases present).
- Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time ≤1.5×ULN.
- Renal function: Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL/min (for males: Cr (mL/min) = (140 - age) × body weight (kg) / [72 × serum creatinine concentration (mg/dL)]; for females: Cr (mL/min) = (140 - age) × body weight (kg) / [85 × serum creatinine concentration (mg/dL)]).
- Females of childbearing potential must agree to use highly effective contraceptive methods during the treatment period and for 5 weeks after the last dose of study drug. Sexually active males must agree to use highly effective contraception during the treatment period and for 3 months after the last dose.
- No difficulty swallowing oral tablets/capsules.
- Good compliance and willingness to adhere to visit schedules, dosing schedules, laboratory tests, and other examination procedures.
Who cannot join
- Patients who have previously received systemic anti-tumor therapy.
- Patients with central nervous system involvement.
- Patients who received systemic adrenal corticosteroids for more than 5 days within 14 days prior to study drug administration, or who require daily doses of >10 mg of dexamethasone or equivalent drugs to control central nervous system disease.
- Active concurrent malignancy requiring active treatment.
- Uncontrolled or severe cardiovascular disease, including (but not limited to) any of the following: congestive heart failure (NYHA class III or IV); myocardial infarction; unstable angina; or presence of arrhythmia requiring treatment at screening, with left ventricular ejection fraction (LVEF) < 50% within 6 months prior to the first dose; primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, undefined cardiomyopathy); clinically significant history of QTc prolongation, second-degree type II atrioventricular block or third-degree atrioventricular block, or QTc interval (Fridericia's method) > 470 ms (female) or > 480 ms (male); atrial fibrillation; patients with uncontrolled hypertension considered unsuitable for participation in the study.
- Uncontrolled infection or infection requiring intravenous antibiotic therapy.
Show all 15Show fewer
- Chronic hepatitis B carriers with active hepatitis B or hepatitis C infection (hepatitis B: acute hepatitis B, untreated chronic hepatitis B virus infection, HBV-DNA ≥ the detection limit of the respective center; hepatitis C: HCV RNA positive) or syphilis. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, subjects with active HBV infection and sustained HBV suppression (HBV DNA < detection limit of the respective center), and subjects cured of HCV may be enrolled.
- Human immunodeficiency virus (HIV) infection.
- Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as active gastrointestinal inflammation, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy, gastric banding surgery, or tumor involvement of the gastrointestinal tract.
- Patients with a history of bleeding disorders, or patients requiring long-term oral anticoagulation due to comorbidities.
- Female subjects who are currently pregnant or breastfeeding.
- Allergy to the study drug or excipients.
- Patients with active psychiatric disorders, alcohol dependence, drug dependence, or substance abuse.
- Presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's opinion, may affect patient safety or compliance with study procedures.
- Other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this clinical trial.
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 First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Changju Qu, 67781865, qcj310@163.com
About this study
Official title: A Prospective, Exploratory Clinical Study of Genetic Subtype-matched Precision Targeted Therapy in Newly Diagnosed DLBCL With TP53 Mutation
To evaluate the efficacy and safety of Genetic subtype-matched targeted therapy in the treatment of treatment-naive diffuse large B-cell lymphoma with TP53 mutation.
Read the detailed description
Using Genetic subtype-matched targeted therapy as first-line treatment for patients with treatment-naive diffuse large B-cell lymphoma (DLBCL) harboring TP53 mutations. The specific Genetic subtype-matched targeted therapy regimen is as follows:
For patients with the MCD/BN2 subtype: Pola-R-CHP + orelabrutinib; For patients with other subtypes: Pola-R-CHP
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Being tested
- POLA-R-CHP, Orelabrutinib
- Keywords
- Polatuzumab vedotin, orelabrutinib, Diffuse Large B-Cell Lymphoma, TP53 mutation
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POLA-R-CHPDrug
Induction treatment period (6 cycles, 21 days/cycle):
Polatuzumab vedotin: 1.8 mg/kg, intravenous drip, Day 1 of each cycle Rituximab: 375 mg/m2, intravenous drip, Day 1 of each cycle CHP/CDP Regimen Cyclophosphamide: 750 mg/m² , intravenous drip, Day 2 of each cycle Doxorubicin: 50 mg/m² , intravenous drip, Day 2 of each cycle or Doxorubicin Hydrochloride Liposome: 25 mg/m² , intravenous drip, Day 2 of each cycle Prednisone: 100 mg, Days 2-6 of each cycle.
Consolidation treatment period (2 cycles, 21 days/cycle):
Rituximab: 375 mg/m2, intravenous drip, Day 1 of each cycle
OrelabrutinibDrug
Induction treatment period (6 cycles, 21 days/cycle)+Consolidation treatment period (2 cycles, 21 days/cycle).
Orelabrutinib: 150mg orally per day from Days 1 to 21 of cycles 2-6 (MCD/BN2)
| Study group | Role | What they receive |
|---|---|---|
| Pola-R-CHP + orelabrutinib or Pola-R-CHP | Experimental | Using Genetic subtype-matched targeted therapy as first-line treatment for patients with treatment-naive diffuse large B-cell lymphoma (DLBCL) harboring TP53 mutations. The specific Genetic subtype-matched targeted therapy regimen is as follows:
Induction treatment period (6 cycles, 21 days/cycle):
For patients with the MCD/BN2 subtype: Pola-R-CHP + orelabrutinib; For patients with other subtypes: Pola-R-CHP Consolidation treatment period (2 cycles, 21 days/cycle)： For patients with the MCD/BN2 subtype: R + orelabrutinib; For patients with other subtypes: R Receives: Drug: POLA-R-CHP; Drug: Orelabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival(PFS)
PFS will be assessed from the start of the treament to date of progression, relapse, death or end of follow-up.
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
Secondary outcomes (2)
Complete response rate(CRR)
The rate of patients who achieved CR after 6 cycles
Measured: At the end of 6 cycles (each cycle is 21 days)
2-year overall survival(OS)
OS will be assessed from the start the treatment to date of death or end of follow-up.
Measured: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- 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
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499271
- Sponsor's protocol ID
- 2026090
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Exploratory Clinical Study of Genetic Subtype-matched Precision Targeted Therapy in Newly Diagnosed DLBCL With TP53 Mutation
- ClinicalTrials.gov ID
- NCT07499271
- Acronym / sponsor ID
- 2026090
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Keywords
- Polatuzumab vedotin, orelabrutinib, Diffuse Large B-Cell Lymphoma, TP53 mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Mar 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.
To evaluate the efficacy and safety of Genetic subtype-matched targeted therapy in the treatment of treatment-naive diffuse large B-cell lymphoma with TP53 mutation.
Detailed description
Using Genetic subtype-matched targeted therapy as first-line treatment for patients with treatment-naive diffuse large B-cell lymphoma (DLBCL) harboring TP53 mutations. The specific Genetic subtype-matched targeted therapy regimen is as follows:
For patients with the MCD/BN2 subtype: Pola-R-CHP + orelabrutinib; For patients with other subtypes: Pola-R-CHP
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pola-R-CHP + orelabrutinib or Pola-R-CHP | Experimental | Drug: POLA-R-CHP, Drug: OrelabrutinibUsing Genetic subtype-matched targeted therapy as first-line treatment for patients with treatment-naive diffuse large B-cell lymphoma (DLBCL) harboring TP53 mutations. The specific Genetic subtype-matched targeted therapy regimen is as follows: Induction treatment period (6 cycles, 21 days/cycle): For patients with the MCD/BN2 subtype: Pola-R-CHP + orelabrutinib; For patients with other subtypes: Pola-R-CHP Consolidation treatment period (2 cycles, 21 days/cycle)： For patients with the MCD/BN2 subtype: R + orelabrutinib; For patients with other subtypes: R |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients aged 18 years and older, up to 70 years.
- Participants must be able to understand and willing to sign the written informed consent form.
- Eastern Cooperative Oncology Group performance status 0 to 3.
- Life expectancy ≥3 months (as determined by the investigator).
- Pathologically (histologically or cytologically) confirmed treatment-naive CD20-positive diffuse large B-cell lymphoma.
Key exclusion criteria (15 listed)
- Patients who have previously received systemic anti-tumor therapy.
- Patients with central nervous system involvement.
- Patients who received systemic adrenal corticosteroids for more than 5 days within 14 days prior to study drug administration, or who require daily doses of >10 mg of dexamethasone or equivalent drugs to control central nervous system disease.
- Active concurrent malignancy requiring active treatment.
- Uncontrolled or severe cardiovascular disease, including (but not limited to) any of the following: congestive heart failure (NYHA class III or IV); myocardial infarction; unstable angina; or presence of arrhythmia requiring treatment at screening, with left ventricular ejection fraction (LVEF) < 50% within 6 months prior to the first dose; primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, undefined cardiomyopathy); clinically significant history of QTc prolongation, second-degree type II atrioventricular block or third-degree atrioventricular block, or QTc interval (Fridericia's method) > 470 ms (female) or > 480 ms (male); atrial fibrillation; patients with uncontrolled hypertension considered unsuitable for participation in the study.
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 |
|---|---|---|
| POLA-R-CHPInduction treatment period (6 cycles, 21 days/cycle): Polatuzumab vedotin: 1.8 mg/kg, intravenous drip, Day 1 of each cycle Rituximab: 375 mg/m2, intravenous drip, Day 1 of each cycle CHP/CDP Regimen Cyclophosphamide: 750 mg/m² , intravenous drip, Day 2 of each cycle Doxorubicin: 50 mg/m² , intravenous drip, Day 2 of each cycle or Doxorubicin Hydrochloride Liposome: 25 mg/m² , intravenous drip, Day 2 of each cycle Prednisone: 100 mg, Days 2-6 of each cycle. Consolidation treatment period (2 cycles, 21 days/cycle): Rituximab: 375 mg/m2, intravenous drip, Day 1 of each cycle | Drug | Pola-R-CHP + orelabrutinib or Pola-R-CHP |
| OrelabrutinibInduction treatment period (6 cycles, 21 days/cycle)+Consolidation treatment period (2 cycles, 21 days/cycle). Orelabrutinib: 150mg orally per day from Days 1 to 21 of cycles 2-6 (MCD/BN2) | Drug | Pola-R-CHP + orelabrutinib or Pola-R-CHP |
Primary outcome
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
PFS will be assessed from the start of the treament to date of progression, relapse, death or end of follow-up.
2 secondary outcomes
Complete response rate(CRR)
Time frame: At the end of 6 cycles (each cycle is 21 days)
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
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 30 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Diffuse Large B-Cell Lymphoma (DLBCL)
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Active, not recruitingPhase 2
Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Diffuse Large B-cell Lymphoma (DLBCL), Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
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 POLA-R-CHP and Orelabrutinib in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by The First Affiliated Hospital of Soochow 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 14 inclusion and 15 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 30 Mar 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 Changju Qu (67781865, qcj310@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 30 Mar 2026.