ClinicalTrials.Veeva

Menu

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

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Completed
Phase 2

Conditions

Lymphoma, Large B-Cell, Diffuse

Treatments

Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT04022005
B2019-091

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

54 participants in 1 patient group

Chidamide combined with R-GemOx
Experimental group
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.
Treatment:
Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin

Trial contacts and locations

1

Loading...

Central trial contact

Qingqing Cai, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems