NCT03373019

Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Chidamide combined with R-GDP	Chidamide: 30mg,PO,biw one week before cycle 1 treatment rituximab 375 mg/m2,ivgtt D0 gemcitabine 1000mg/m2 iv D1,8 dexamethasone 40mg, iv D1-4, cisplatin 25mg/m2 iv D1-4 chidamide :20mg PO Biw, 2 week on , 1 week off

Timeline

• Start date: 2017-12-21
• Primary completion: 2019-06-30
• Completion: 2021-03-01
• First posted: 2017-12-14
• Last updated: 2017-12-14

Locations

2 sites across 1 country: China