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

Primary Purpose

Lymphoma, Large B-Cell, Diffuse

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide, Rituximab, Gemcitabine,Oxaliplatin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • biopsy proved CD20+ DLBCL;
  • first relapse or refractory；
  • 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 more than one chemotherapy regimen;
  • patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chidamide combined with R-GemOx

Arm Description

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.

Outcomes

Primary Outcome Measures

ORR
the proportion of patients who had CR, and PR according to the revised 2014 Lugano criteria for response assessment of lymphoma.

Secondary Outcome Measures

DOR
the time from the first CR or PR to the first documented progressive disease (PD) or death, whichever occurred earlier.
PFS
the time from the date of enrollment until either PD or death.
OS
the time from the date of enrollment until death

Full Information

First Posted
July 13, 2019
Last Updated
September 6, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04022005
Brief Title
Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
November 16, 2022 (Actual)
Study Completion Date
March 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chidamide combined with R-GemOx
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chidamide, Rituximab, Gemcitabine,Oxaliplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
ORR
Description
the proportion of patients who had CR, and PR according to the revised 2014 Lugano criteria for response assessment of lymphoma.
Time Frame
4-years
Secondary Outcome Measure Information:
Title
DOR
Description
the time from the first CR or PR to the first documented progressive disease (PD) or death, whichever occurred earlier.
Time Frame
4-years
Title
PFS
Description
the time from the date of enrollment until either PD or death.
Time Frame
4-years
Title
OS
Description
the time from the date of enrollment until death
Time Frame
4-years
Other Pre-specified Outcome Measures:
Title
bio-marker analysis
Description
Correlation between epigenetic factor mutation and efficacy
Time Frame
4-years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
51000
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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