NCT04022005

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2019

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

3.4 years

First QC Date

July 13, 2019

Last Update Submit

September 6, 2023

Conditions

Lymphoma, Large B-Cell, Diffuse

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • DOR

    4-years

  • PFS

    4-years

  • OS

    4-years

Other Outcomes (1)

  • bio-marker analysis

    4-years

Study Arms (1)

Chidamide combined with R-GemOx

EXPERIMENTAL

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

Interventions

Chidamide, Rituximab, Gemcitabine,OxaliplatinDRUG

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.

Chidamide combined with R-GemOx

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • years; without other malignancy;
  • proper functioning of the major organs.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 51000, China

Location

Related Publications (1)

  • 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.

    PMID: 40318003DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamideRituximabGemcitabineOxaliplatin

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

July 13, 2019

First Posted

July 16, 2019

Study Start

June 19, 2019

Primary Completion

November 16, 2022

Study Completion

March 11, 2023

Last Updated

September 11, 2023

Record last verified: 2023-09

Locations

CN(1)