DHLPhase 2NCT07552324
Study on the Treatment of Double/Triple-hit DLBCL With Chidamide and Lisaftoclax in Combination With Pola-R-CHP
A Phase 2 study testing CL-Pola-R-CHP in people with DHL and THL, run by Ruijin Hospital.
Trial summary
This is an open-label, multicenter clinical study for patients aged 65 and above with double/triple-hit diffuse large B-cell lymphoma who are not suitable for transplantation. The study employs a 6-cycle CL-Pola-R-CHP regimen, with cycles repeated every 21 days. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- DHL, THL, DLBCL - Diffuse Large B Cell Lymphoma
- What is being tested?
- CL-Pola-R-CHP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 May 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histopathological diagnosis confirmed as diffuse large B-cell lymphoma, with CD20 positivity;
- Double or triple hit confirmed by pathology;
- Age ≥ 65 years old;
- ECOG performance status score of 0, 1, or 2;
- No history of malignant tumor; no concurrent occurrence of other tumors;
- Patients whose life expectancy is at least 6 months, as determined by the researcher;
- The patient or their legal guardian must provide written informed consent before undergoing any special examinations or procedures in the study.
- International Prognostic Index (IPI) > 1 point.
Who cannot join
- There is a history of other malignant tumors, excluding basal cell carcinoma and cervical carcinoma in situ;
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc;
- Primary central nervous system lymphoma;
- Left ventricular ejection fraction (LVEF) is less than or equal to 50%;
- Laboratory test values during screening: (unless caused by lymphoma); A. Neutrophil count <1.5*10^9/L; B. Platelet count <75*10^9/L; C. ALT or AST is more than twice the upper limit of normal, and AKP and bilirubin are more than 1.5 times the upper limit of normal; D. Creatinine level is higher than 1.5 times the upper limit of normal;
- Other concurrent and uncontrolled medical conditions that the researcher believes will affect the patient's participation in the study.
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- Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
- Pregnant or lactating women;
- HIV-infected individuals.
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Treatment of Double/Triple-hit Diffuse Large B-cell Lymphoma With Chidamide and Lisaftoclax in Combination With Vepesidil, Rituximab, Cyclophosphamide, Adriamycin, and Prednisone (CL-Pola-R-CHP)
This is an open-label, multicenter clinical study for patients aged 65 and above with double/triple-hit diffuse large B-cell lymphoma who are not suitable for transplantation. The study employs a 6-cycle CL-Pola-R-CHP regimen, with cycles repeated every 21 days.
- Conditions
- DHL, THL, DLBCL - Diffuse Large B Cell Lymphoma
- Being tested
- CL-Pola-R-CHP
- Keywords
- DHL, THL, DLBCL, 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.
CL-Pola-R-CHPDrug
R 375 mg/m2 D1 Pola 1.8mg/kg D1 CTX 750mg/m2 D2 ADR 50mg/m2 D2 Pred 60 mg/m2 D2-6 Chidamide 20mg/d D1,4,8,11 Lisaftoclax 600mg/d D1-21
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | CL-Pola-R-CHP Receives: Drug: CL-Pola-R-CHP |
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)
1-year progression-free survival (PFS) rate
Measured: 1 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 posted27 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DHLStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552324
- Sponsor's protocol ID
- CL-Pola-R-CHP
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 Apr 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Treatment of Double/Triple-hit Diffuse Large B-cell Lymphoma With Chidamide and Lisaftoclax in Combination With Vepesidil, Rituximab, Cyclophosphamide, Adriamycin, and Prednisone (CL-Pola-R-CHP)
- ClinicalTrials.gov ID
- NCT07552324
- Acronym / sponsor ID
- CL-Pola-R-CHP
- Conditions
- DHL, THL, DLBCL - Diffuse Large B Cell Lymphoma
- Keywords
- DHL, THL, DLBCL, Chidamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 27 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.
This is an open-label, multicenter clinical study for patients aged 65 and above with double/triple-hit diffuse large B-cell lymphoma who are not suitable for transplantation. The study employs a 6-cycle CL-Pola-R-CHP regimen, with cycles repeated every 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: CL-Pola-R-CHPCL-Pola-R-CHP |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Histopathological diagnosis confirmed as diffuse large B-cell lymphoma, with CD20 positivity;
- Double or triple hit confirmed by pathology;
- Age ≥ 65 years old;
- ECOG performance status score of 0, 1, or 2;
- No history of malignant tumor; no concurrent occurrence of other tumors;
Key exclusion criteria (10 listed)
- There is a history of other malignant tumors, excluding basal cell carcinoma and cervical carcinoma in situ;
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc;
- Primary central nervous system lymphoma;
- Left ventricular ejection fraction (LVEF) is less than or equal to 50%;
- Laboratory test values during screening: (unless caused by lymphoma); A. Neutrophil count <1.5*10^9/L; B. Platelet count <75*10^9/L; C. ALT or AST is more than twice the upper limit of normal, and AKP and bilirubin are more than 1.5 times the upper limit of normal; D. Creatinine level is higher than 1.5 times the upper limit of normal;
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 |
|---|---|---|
| CL-Pola-R-CHPR 375 mg/m2 D1 Pola 1.8mg/kg D1 CTX 750mg/m2 D2 ADR 50mg/m2 D2 Pred 60 mg/m2 D2-6 Chidamide 20mg/d D1,4,8,11 Lisaftoclax 600mg/d D1-21 | Drug | Treatment Group |
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
1-year progression-free survival (PFS) rate
Time frame: 1 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 27 Apr 2026.
Related trials for DHL
Not yet recruitingPhase 1/2
Pola-R-CHP Plus Sonrotoclax in Untreated BCL2-High/Double-Hit LBCL
Large B-cell Lymphoma
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CL-Pola-R-CHP in people with DHL and THL, run by Ruijin Hospital.
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 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: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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 27 Apr 2026.