Study on the Treatment of Double/Triple-hit DLBCL With Chidamide and Lisaftoclax in Combination With Pola-R-CHP

April 20, 2026 updated by: Ruijin Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
CL-Pola-R-CHP
Drug: CL-Pola-R-CHP
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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]
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

Secondary Outcome Measures

Outcome Measure
Time Frame
2-year overall survival (OS) rate
Time Frame: 2 years after enrollment
2 years after enrollment
1-year progression-free survival (PFS) rate
Time Frame: 1 years after enrollment
1 years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-Pola-R-CHP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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