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

September 6, 2023 updated by: Qingqing Cai, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 51000
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 4-years
the proportion of patients who had CR, and PR according to the revised 2014 Lugano criteria for response assessment of lymphoma.
4-years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DOR
Time Frame: 4-years
the time from the first CR or PR to the first documented progressive disease (PD) or death, whichever occurred earlier.
4-years
PFS
Time Frame: 4-years
the time from the date of enrollment until either PD or death.
4-years
OS
Time Frame: 4-years
the time from the date of enrollment until death
4-years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
bio-marker analysis
Time Frame: 4-years
Correlation between epigenetic factor mutation and efficacy
4-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2019

Primary Completion (Actual)

November 16, 2022

Study Completion (Actual)

March 11, 2023

Study Registration Dates

First Submitted

July 13, 2019

First Submitted That Met QC Criteria

July 13, 2019

First Posted (Actual)

July 16, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2019-091

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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