Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT07552324
NCT07552324Not yet recruitingPhase 2

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)

Ruijin Hospital0 sites28 target enrollmentStarted: May 1, 2026Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
28
Primary Endpoint
Complete remission (CR) rate
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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;

Arms & Interventions

Treatment Group

Experimental

CL-Pola-R-CHP

Intervention: CL-Pola-R-CHP (Drug)

Outcomes

Primary Outcomes

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]

Secondary Outcomes

  • 1-year progression-free survival (PFS) rate(1 years after enrollment)
  • 2-year overall survival (OS) rate(2 years after enrollment)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Similar Trials

Not yet recruiting
Phase 4
A clinical trial to study and compare the effect of two different antibiotic regimen in treating Helicobacter pylori infection.
CTRI/2024/09/073256Intramural Research Fund Committee168
Recruiting
Not Applicable
Double-Dose Third-Generation EGFR-TKI Plus Bevacizumab and Intrathecal Chemotherapy for Refractory Leptomeningeal Metastatic NSCLC: A Phase II Study
NCT07398599Second Affiliated Hospital of Nanchang University30
Recruiting
Phase 4
Efficacy of Triple versus Dual Therapy in COPD Using Surfactant Protein-D as a Biomarker
CTRI/2025/02/080369SRMIST224
Recruiting
Phase 1
Treatment of Participants With Primary or Secondary Progressive Multiple SclerosisPrimary Progressive Multiple SclerosisMultiple Sclerosis
NCT07477639Tr1X, Inc.39
Not yet recruiting
Not Applicable
A Clinical Study to Test the Safety and efficacy of test treatment for improving visible signs of facial aging such as wrinkles, fine lines, and dark spots.
CTRI/2025/07/091149Ambe Phytoextracts Pvt. Ltd81