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

Lymphoma, Large B-Cell, Diffuse Clinical Trial

Official title:

Chidamide Combined With R-GemOx(Rituximab、Gemcitabine Plus Oxaliplatin) Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Multi-center, Single Arm, Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04022005
• Other study ID #: B2019-091
• Status: Completed
• Phase: Phase 2
• Start date: June 19, 2019
• Est. completion date: March 11, 2023

Study information

• Verified date: September 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 11, 2023
• Est. primary completion date: November 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	bio-marker analysis	Correlation between epigenetic factor mutation and efficacy	4-years
Primary	ORR	the proportion of patients who had CR, and PR according to the revised 2014 Lugano criteria for response assessment of lymphoma.	4-years
Secondary	DOR	the time from the first CR or PR to the first documented progressive disease (PD) or death, whichever occurred earlier.	4-years
Secondary	PFS	the time from the date of enrollment until either PD or death.	4-years
Secondary	OS	the time from the date of enrollment until death	4-years