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

  NCT04022005

  CompletedInterventionalPhase 2Updated Sep 11, 2023
• Chidamide Combined With VDDT Regimen in the Relapse and Refractory Diffuse Large B Cell Lymphoma

  NCT02733380

  Unknown statusInterventionalPhase 2Updated Apr 1, 2020
• Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients

  NCT05823701

  Unknown statusInterventionalPhase 2Updated Apr 21, 2023
• Chidamide in Patients With Recurrent and Refractory Diffuse Large b

  NCT05690191

  Unknown statusObservationalUpdated Jan 19, 2023
• Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

  NCT03410004

  Unknown statusInterventionalPhase 2Updated Jan 25, 2018
• Chidamide With R-CHOP Regimen for DLBCL Patients

  NCT03201471

  Unknown statusInterventionalPhase 2Updated Aug 2, 2018

ClinicalTrials.gov ID

NCT03373019

Lead Sponsor

Fudan UniversityOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

63Estimated

Last Update Posted

Dec 14, 2017Actual

Start Date

Dec 21, 2017Estimated

Primary Completion Date

Jun 30, 2019Estimated

Completion Date

Mar 1, 2021Estimated

Official Title

A Non-randomized, Open-label, Phase II Study of Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Not Suitable for Transplantation

Brief Summary

The goal of this clinical trial is to evaluate therapeutic efficacy of Chidamide combined with R-GDP （rituximab/gemcitabine/dexamethasone/cisplatin）in treating Patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.

Detailed Description

The treatment outcome of patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) are not satisfactory especially for those not suitable for transplantation. One of main reason is chemotherapy resistance. The investigators conducted this study to evaluate the efficacy of Chidamide combined with R-GDP(rituximab/gemcitabine/dexamethasone/cisplatin) in treating patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation. Chidamide is a novel benzamide type of subtype-selective histone deacetylase (HDAC) inhibitor. It has been approved by China Food and Drug Administration (CFDA) for treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) in Chinese population. The investigators' pre-clinical data suggested that this agent might be also efficient in the treatment of relapsed/refractory B cell lymphoma. In this open-label, non-randomized, phase II study, the investigators aimed to observe the efficacy and safety of chidamide combined with R-GDP in patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.

• Chidamide
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Neoplasm by Histology
• Neoplasms
• Lymphoproliferative Disorders
• Lymphatic Diseases
• Immunoproliferative Disorders
• Immune System Diseases
• Lymphoma, Non-Hodgkin
• Cyclophosphamide
• Rituximab
• Gemcitabine
• Cisplatin
• Dexamethasone
• HDAC Inhibitor

• Chidamide combined with R-GDP

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Ages: 18-75 years old
2. Relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) previous treated with standard chemoimmunotherapy
3. Not willing or not suitable for hematopoietic stem cell transplantation (HSCT)
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) index < 2
5. Informed consent available
6. Life expectancy of more than 3 months;
7. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
8. Bone marrow function: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L, Hb ≥ 80g/L;
9. Liver function: total bilirubin, ALT and AST were <1.5 × UNL (the upper limit of normal value)
10. Renal function: Cr<1.5 × UNL and creatinine clearance > 50ml/min

Exclusion Criteria:

1. Prior history of treatment of HDAC inhibitor.
2. Plan of HSCT in the future
3. Significant pericardial effusion showed by chest CT scan
4. Prior history of other cancers except treated cervical or basal cell skin carcinoma, organ transplantation
5. Syphilis or human immunodeficiency virus (HIV) infection
6. Pregnant or lactating women
7. History of organ transplantation
8. Serious active infections (including hepatitis)
9. Serious neurological or psychiatric history, including dementia or epilepsy.

Termination criteria:

1. Withdrew consent
2. Researchers think it is necessary to terminate the study;
3. Disease progression or death;
4. Poor compliance
5. Subclinical or clinical cardiac toxicity;
6. Unable to continue treatment because of severe toxicity

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Fudan UniversityOTHER

xuekaishanghai@126.com13818659448