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Completed

NCT Number: NCT04022005

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

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.

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Key information

Conditions

Lymphoma, Large B-Cell, Diffuse Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Guangzhou, Guangdong, 51000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Chidamide, Rituximab, Gemcitabine,Oxaliplatin

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. PFS

    Time frame: 4-years

    the time from the date of enrollment until either PD or death.

  3. OS

    Time frame: 4-years

    the time from the date of enrollment until death

Other outcomes

  1. bio-marker analysis

    Time frame: 4-years

    Correlation between epigenetic factor mutation and efficacy

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jul 16, 2019
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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