DLBCL - Diffuse Large B Cell LymphomaPhase 3NCT07511114
A Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated DEL Under the Guidance of Genotyping
A Phase 3 study testing C-Pola-R-CHP+X and CR-CHOP in people with DLBCL - Diffuse Large B Cell Lymphoma and Double Expressor Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
Evaluate the efficacy and safety of C Pola R-CHP+X compared to CR-CHOP in the treatment of previously untreated patients with DEL Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma, Double Expressor Lymphoma
- What is being tested?
- C-Pola-R-CHP+X and CR-CHOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 31 Mar 2030
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histopathological diagnosis confirmed as diffuse large B-cell lymphoma, with CD20 positivity;
- 2. Simultaneous expression of MYC and BCL2, according to the WHO standard for immunohistochemistry: MYC ≥ 40%, BCL2 ≥ 50%
- 3. Age ≥ 18 years old and ≤ 75 years old;
- 4. ECOG performance status score of 0, 1, or 2;
- 5. International Prognostic Index (IPI) > 1
- 6. No history of malignant tumor; no concurrent occurrence of other tumors;
- 7. Patients with an expected lifespan of at least 6 months, as determined by the researcher;
- 8. The patient or their legal representative must provide written informed consent before undergoing any special examinations or procedures in the study.
Who cannot join
- 1. Have previously received systemic or local treatments, including chemotherapy;
- 2. Have previously undergone autologous stem cell transplantation;
- 3. Previously had a history of other malignant tumors, excluding basal cell carcinoma and cervical carcinoma in situ;
- 4. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc;
- 5. Primary central nervous system lymphoma;
- 6. Left ventricular ejection fraction (LVEF) is less than or equal to 50%;
Show all 12Show fewer
- 7. Laboratory test values during screening: (unless caused by lymphoma); A. Neutrophil count <1.5*10^9/L; B. Platelet count < 75 x 10^9/L; C. ALT or AST is 2 times higher than the upper limit of normal, and AKP and bilirubin are 1.5 times higher than the upper limit of normal; D. Creatinine level is higher than 1.5 times the upper limit of normal;
- 8. Other concurrent and uncontrolled medical conditions that the researcher believes will affect the patient's participation in the study.
- 9. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
- 10. Pregnant or lactating women;
- 11. Individuals infected with HIV.
- 12. Patients with positive HBsAg test results must undergo HBV DNA testing and can only be enrolled after becoming negative. Additionally, if the HBsAg test result is negative but the HBcAb test result is positive (regardless of the HBsAb status), HBV DNA testing is also required. If the result is positive, treatment must be administered until becoming negative before enrollment;
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
No. 197 Ruijin 2nd Road, Huangpu District, Shanghai, Shanghai, Shanghai
Shanghai
Li Wang, 18917762217, dr_wangli@126.com
About this study
Official title: A Prospective, Open-label, Multicenter, Randomized Controlled Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated Double-expression Diffuse Large B-cell Lymphoma Under the Guidance of Genotyping
Evaluate the efficacy and safety of C Pola R-CHP+X compared to CR-CHOP in the treatment of previously untreated patients with DEL
Read the detailed description
This is a prospective, open-label, multicenter, randomized controlled clinical study conducted among previously untreated CD20-positive DEL participants. Subjects who meet the inclusion/exclusion criteria will be randomly assigned in a 1:1 ratio to either the test group or the control group after signing the informed consent form:
The experimental group first received one course of CR-CHOP regimen, and then the subsequent treatment was determined based on whether the ctDNA LFC reached 3 after one cycle of CR-CHOP treatment.
Perform ctDNA detection at C1D14, and continue CR-CHOP treatment for patients with C1D14 ctDNA LFC ≥ 3 until 6 cycles.
For patients with C1D14 ctDNA LFC < 3, stratification based on gene subtypes is conducted into C1, C2-3, and TP53mut types, which determines the medication for the remaining 5 cycles. For C1 type, PD1 inhibitors are added; for C2 and C3 types, BTK inhibitors are added; for TP53mut type, decitabine is added.
If assigned to the control group, they will continue to receive CR-CHOP for up to 6 cycles.
After each chemotherapy session, a routine evaluation is conducted. After completing three sessions, a comprehensive objective efficacy evaluation is performed. Patients with CR or PR in the efficacy evaluation continue with the original treatment regimen. For patients with SD or PD, second-line salvage therapy is recommended. After completing all treatments, the first summary evaluation is conducted. Patients with CR enter maintenance therapy with chidamide (maintenance for 2 years is recommended unless intolerable toxicity occurs or disease progresses) or undergo autologous hematopoietic stem cell transplantation. If CR is not achieved, the second-line regimen should be switched. After a follow-up of 2 years, the second summary evaluation is conducted. Before treatment, patients with large tumors may be recommended for radiation therapy in the corresponding area based on the doctor's judgment after completing six sessions of treatment (radiation dose is 30-40 Gy; however, it mainly depends on specific treatment principles). Additionally, the treating physician may decide whether to perform radiation therapy for extranodal lesions based on specific circumstances.
- Being tested
- C-Pola-R-CHP+X, CR-CHOP
- Keywords
- DLBCL, DEL, Chidamide
- 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.
C-Pola-R-CHP+XDrug
The experimental group first received one course of CR-CHOP regimen, and then the subsequent treatment was determined based on whether the ctDNA LFC reached 3 after one cycle of CR-CHOP treatment.
Perform ctDNA detection at C1D14, and continue CR-CHOP treatment for patients with C1D14 ctDNA LFC ≥ 3 until 6 cycles.
For patients with C1D14 ctDNA LFC < 3, stratification is based on gene subtypes, namely C1, C2-3, and TP53mut, which determines the medication for the remaining 5 cycles. For C1 subtype, a PD1 inhibitor is added; for C2 and C3 subtypes, a BTK inhibitor is added; for TP53mut subtype, decitabine is added.
CR-CHOPDrug
If assigned to the control group, they will continue to receive CR-CHOP for up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Innovative Treatment Group | Experimental | The experimental group first received one course of CR-CHOP regimen, and then the subsequent treatment was determined based on whether the ctDNA LFC reached 3 after one cycle of CR-CHOP treatment.
Perform ctDNA detection at C1D14, and continue CR-CHOP treatment for patients with C1D14 ctDNA LFC ≥ 3 until 6 cycles.
For patients with C1D14 ctDNA LFC < 3, stratification based on gene subtypes is conducted into C1, C2-3, and TP53mut types, which determines the medication for the remaining 5 cycles. For C1 type, PD1 inhibitors are added; for C2 and C3 types, BTK inhibitors are added; for TP53mut type, decitabine is added. Receives: Drug: C-Pola-R-CHP+X |
| CR-CHOP | Active comparator | Not described Receives: Drug: CR-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (CR) rate
Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Secondary outcomes (2)
2-year progression-free survival (PFS) rate
Measured: 2 years after enrollment
2-year overall survival (OS) rate
Measured: 2 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2030 (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.
- More trials run by Ruijin HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511114
- Sponsor's protocol ID
- C-pola-R-CHP+X
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 6 Apr 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Multicenter, Randomized Controlled Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated Double-expression Diffuse Large B-cell Lymphoma Under the Guidance of Genotyping
- ClinicalTrials.gov ID
- NCT07511114
- Acronym / sponsor ID
- C-pola-R-CHP+X
- Keywords
- DLBCL, DEL, Chidamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 6 Apr 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.
Evaluate the efficacy and safety of C Pola R-CHP+X compared to CR-CHOP in the treatment of previously untreated patients with DEL
Detailed description
This is a prospective, open-label, multicenter, randomized controlled clinical study conducted among previously untreated CD20-positive DEL participants. Subjects who meet the inclusion/exclusion criteria will be randomly assigned in a 1:1 ratio to either the test group or the control group after signing the informed consent form:
The experimental group first received one course of CR-CHOP regimen, and then the subsequent treatment was determined based on whether the ctDNA LFC reached 3 after one cycle of CR-CHOP treatment.
Perform ctDNA detection at C1D14, and continue CR-CHOP treatment for patients with C1D14 ctDNA LFC ≥ 3 until 6 cycles.
For patients with C1D14 ctDNA LFC < 3, stratification based on gene subtypes is conducted into C1, C2-3, and TP53mut types, which determines the medication for the remaining 5 cycles. For C1 type, PD1 inhibitors are added; for C2 and C3 types, BTK inhibitors are added; for TP53mut type, decitabine is added.
If assigned to the control group, they will continue to receive CR-CHOP for up to 6 cycles.
After each chemotherapy session, a routine evaluation is conducted. After completing three sessions, a comprehensive objective efficacy evaluation is performed. Patients with CR or PR in the efficacy evaluation continue with the original treatment regimen. For patients with SD or PD, second-line salvage therapy is recommended. After completing all treatments, the first summary evaluation is conducted. Patients with CR enter maintenance therapy with chidamide (maintenance for 2 years is recommended unless intolerable toxicity occurs or disease progresses) or undergo autologous hematopoietic stem cell transplantation. If CR is not achieved, the second-line regimen should be switched. After a follow-up of 2 years, the second summary evaluation is conducted. Before treatment, patients with large tumors may be recommended for radiation therapy in the corresponding area based on the doctor's judgment after completing six sessions of treatment (radiation dose is 30-40 Gy; however, it mainly depends on specific treatment principles). Additionally, the treating physician may decide whether to perform radiation therapy for extranodal lesions based on specific circumstances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Innovative Treatment Group | Experimental | Drug: C-Pola-R-CHP+XThe experimental group first received one course of CR-CHOP regimen, and then the subsequent treatment was determined based on whether the ctDNA LFC reached 3 after one cycle of CR-CHOP treatment. Perform ctDNA detection at C1D14, and continue CR-CHOP treatment for patients with C1D14 ctDNA LFC ≥ 3 until 6 cycles. For patients with C1D14 ctDNA LFC < 3, stratification based on gene subtypes is conducted into C1, C2-3, and TP53mut types, which determines the medication for the remaining 5 cycles. For C1 type, PD1 inhibitors are added; for C2 and C3 types, BTK inhibitors are added; for TP53mut type, decitabine is added. |
| CR-CHOP | Active comparator | Drug: CR-CHOP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Histopathological diagnosis confirmed as diffuse large B-cell lymphoma, with CD20 positivity;
- 2. Simultaneous expression of MYC and BCL2, according to the WHO standard for immunohistochemistry: MYC ≥ 40%, BCL2 ≥ 50%
- 3. Age ≥ 18 years old and ≤ 75 years old;
- 4. ECOG performance status score of 0, 1, or 2;
- 5. International Prognostic Index (IPI) > 1
Key exclusion criteria (12 listed)
- 1. Have previously received systemic or local treatments, including chemotherapy;
- 2. Have previously undergone autologous stem cell transplantation;
- 3. Previously had a history of other malignant tumors, excluding basal cell carcinoma and cervical carcinoma in situ;
- 4. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc;
- 5. Primary central nervous system lymphoma;
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 |
|---|---|---|
| C-Pola-R-CHP+XThe experimental group first received one course of CR-CHOP regimen, and then the subsequent treatment was determined based on whether the ctDNA LFC reached 3 after one cycle of CR-CHOP treatment. Perform ctDNA detection at C1D14, and continue CR-CHOP treatment for patients with C1D14 ctDNA LFC ≥ 3 until 6 cycles. For patients with C1D14 ctDNA LFC < 3, stratification is based on gene subtypes, namely C1, C2-3, and TP53mut, which determines the medication for the remaining 5 cycles. For C1 subtype, a PD1 inhibitor is added; for C2 and C3 subtypes, a BTK inhibitor is added; for TP53mut subtype, decitabine is added. | Drug | Innovative Treatment Group |
| CR-CHOPIf assigned to the control group, they will continue to receive CR-CHOP for up to 6 cycles. | Drug | CR-CHOP |
Primary outcome
Complete remission (CR) rate
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
2 secondary outcomes
2-year progression-free survival (PFS) rate
Time frame: 2 years after enrollment
2-year overall survival (OS) rate
Time frame: 2 years after enrollment
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 6 Apr 2026.
- Individual participant dataSharing planned: No
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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 3 study testing C-Pola-R-CHP+X and CR-CHOP in people with DLBCL - Diffuse Large B Cell Lymphoma and Double Expressor Lymphoma, run by Ruijin Hospital 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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 6 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Li Wang (18917762217, dr_wangli@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (CR) rate (time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]). 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 6 Apr 2026.