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
Sponsored by
About this trial
This is an interventional treatment trial for Chidamide focused on measuring chidamide, R-GDP, diffuse large B-cell lymphoma
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
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
CR
complete response
OS
overall survival
3 year PFS
3 year progression free survival
adverse event
adverse event related to treatment
Full Information
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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
Intervention Type
Drug
Intervention Name(s)
Chidamide combined with R-GDP
Intervention 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
Primary Outcome Measure Information:
Title
ORR
Description
overall response rate
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
CR
Description
complete response
Time Frame
6 weeks
Title
OS
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
No
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
Email
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
Email
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
Email
xuekaishanghai@126.com
First Name & Middle Initial & Last Name & Degree
Junning Cao, MD
Phone
13818659448
12. IPD Sharing Statement
Plan to Share IPD
No
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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