NCT07552324Not yet recruitingPhase 2
Study on the Treatment of Double/Triple-hit DLBCL With Chidamide and Lisaftoclax in Combination With Pola-R-CHP
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)
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 20 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- Ruijin Hospital
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT07552324
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 28
- From 1 May 2026 to the primary completion date, 31 May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other concurrent and uncontrolled medical conditions that the researcher believes will affect the patient's participation in the study.
Other illness
- 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;
- Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
- 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;
Lab values
- 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
- Primary central nervous system lymphoma;
- Pregnant or lactating women;
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.