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

NCT07552324 | Not Yet Recruiting Phase 2

• 1 other identifier: CL-Pola-R-CHP
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

DHL; THL; DLBCL - Diffuse Large B Cell Lymphoma

Keywords

DHL; THL; DLBCL; Chidamide

Outcome Measures

Primary Outcomes (1)

• Complete remission (CR) rate

  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

  1 years after enrollment

• 2-year overall survival (OS) rate

  2 years after enrollment

Study Arms (1)

Treatment Group

EXPERIMENTAL

CL-Pola-R-CHP

Drug: CL-Pola-R-CHP

Interventions

CL-Pola-R-CHP DRUG

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

Treatment Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Li Wang

CONTACT

18917762217; dr_wangli@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04