Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL

NCT ID: NCT04022005

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-19
• Study Completion Date: 2023-03-11

Brief Summary

The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.

Conditions

Lymphoma, Large B-Cell, Diffuse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chidamide combined with R-GemOx

Chidamide, 20 mg,twice per week; Rituximab 375mg/m2, d1, intravenous drip; Gemcitabine 1000mg/m2, d2, intravenous drip; Oxaliplatin 100mg/m2, d2,intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive chidamide maintenance therapy.

Group Type: EXPERIMENTAL

Chidamide, Rituximab, Gemcitabine,Oxaliplatin

Intervention Type: DRUG

All patients enrolled in the study will accept Chidamide + R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) as their salvage chemotherapy.

Patients with CR or PR will receive chidamide maintenance therapy.

Interventions

Chidamide, Rituximab, Gemcitabine,Oxaliplatin

All patients enrolled in the study will accept Chidamide + R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) as their salvage chemotherapy.

Patients with CR or PR will receive chidamide maintenance therapy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• biopsy proved CD20+ DLBCL;
• relapse or refractory DLBCL#
• previously received systemic chemotherapy with anthracycline#
• not eligible for autologous hematopoietic stem cell transplantation#
• at least one evaluable lesion#
• ECOG PS 0-1;
• 18-75 years; without other malignancy;
• proper functioning of the major organs.

Exclusion Criteria

• double-hit lymphoma;
• previously received treatment of HDAC inhibitor;
• plan to receive autologous stem cell transplantation;
• involvement of central nervous system;
• previously received gemcitabine within the past 6 months;
• patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Qingqing Cai

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Countries

China

References

Zou Q, Zhang Y, Zhou H, Lai Y, Cao Y, Li Z, Su N, Li W, Huang H, Liu P, Ye X, Wu Y, Tan H, Zheng R, Wu B, Yang H, Zhong L, Lu Y, Liang Y, Sun P, Li L, Liu Y, Dai D, Xia Y, Cai Q. Chidamide, a Histone Deacetylase Inhibitor, Combined With R-GemOx in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (TRUST): A Multicenter, Single-Arm, Phase 2 Trial. Cancer Med. 2025 May;14(9):e70919. doi: 10.1002/cam4.70919.

Reference Type: DERIVED

PMID: 40318003 (View on PubMed)

Other Identifiers

B2019-091

Identifier Type: -

Identifier Source: org_study_id