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

Primary Purpose

Chidamide, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Chidamide combined with R-GDP

About this trial

This is an interventional treatment trial for Chidamide focused on measuring chidamide, R-GDP, diffuse large B-cell lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Termination criteria:

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

Sites / Locations

Kai XueRecruiting
Kai XueRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chidamide combined with R-GDP

Arm Description

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

Outcomes

Primary Outcome Measures

ORR

overall response rate

Secondary Outcome Measures

complete response

overall survival

3 year PFS

3 year progression free survival

adverse event

adverse event related to treatment

Full Information

NCT ID

NCT03373019

First Posted

November 30, 2017

Last Updated

December 12, 2017

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03373019

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 21, 2017 (Anticipated)

Primary Completion Date

June 30, 2019 (Anticipated)

Study Completion Date

March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

chidamide, R-GDP, diffuse large B-cell lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chidamide combined with R-GDP

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Chidamide combined with R-GDP

Intervention Description

Primary Outcome Measure Information:

Title

ORR

Description

overall response rate

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Description

complete response

Time Frame

6 weeks

Title

Description

overall survival

Time Frame

3 years

Title

3 year PFS

Description

3 year progression free survival

Time Frame

3 years

Title

adverse event

Description

adverse event related to treatment

Time Frame

throughout the treatment period，up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ages: 18-75 years old Relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) previous treated with standard chemoimmunotherapy Not willing or not suitable for hematopoietic stem cell transplantation (HSCT) Eastern Cooperative Oncology Group (ECOG) performance status (PS) index < 2 Informed consent available Life expectancy of more than 3 months; Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention. Bone marrow function: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L, Hb ≥ 80g/L; Liver function: total bilirubin, ALT and AST were <1.5 × UNL (the upper limit of normal value) Renal function: Cr<1.5 × UNL and creatinine clearance > 50ml/min Exclusion Criteria: Prior history of treatment of HDAC inhibitor. Plan of HSCT in the future Significant pericardial effusion showed by chest CT scan Prior history of other cancers except treated cervical or basal cell skin carcinoma, organ transplantation Syphilis or human immunodeficiency virus (HIV) infection Pregnant or lactating women History of organ transplantation Serious active infections (including hepatitis) Serious neurological or psychiatric history, including dementia or epilepsy. Termination criteria: Withdrew consent Researchers think it is necessary to terminate the study; Disease progression or death; Poor compliance Subclinical or clinical cardiac toxicity; Unable to continue treatment because of severe toxicity

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kai Xue, MD

Phone

13818659448

xuekaishanghai@126.com

Facility Information:

Facility Name

Kai Xue

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kai Xue, MD

Phone

13818659448

xuekaishanghai@126.com

Facility Name

Kai Xue

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kai Xue, MD

Phone

13818659448

xuekaishanghai@126.com

First Name & Middle Initial & Last Name & Degree

Junning Cao, MD

Phone

13818659448

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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