Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Primary Purpose
Experimental
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Chidamide
Sponsored by
About this trial
This is an interventional treatment trial for Experimental
Eligibility Criteria
Inclusion Criteria:
- Diagnosed as Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) according to "2016 WHO classification of tumors of haematopoietic and lymphoid tissues";
- Patients must have received systemic treatment (including chemotherapy or Hematopoietic stem cell transplantation), but did not achieve remission or had relapse after remission;
- At least one measurable lesion;
- Age 18-75 years, male or female;
- ECOG performance status 0-1;
- Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;.
- Life expectancy no less than 3 months;
- Not received chemotherapy, targeted medicine or stem cell transplantation 3 weeks before enrollment;
- Patients have signed the Informed Consent Form.
Exclusion Criteria:
- Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
- QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
- pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
- Patients have undergone organ transplantation;
- Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
- Patients with active hemorrhage.
- Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
- Patients with active infection, or with continuous fever within 14 days prior to enrollment.
- Had major organ surgery within 6 weeks prior to enrollment.
- Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum).
- Patients with mental disorders or those do not have the ability to consent.
- Patients with drug abuse, long term alcoholism that may impact the results of the trial.
- Patients who have central nervous system involvements;
- Non-appropriate patients for the trial according to the judgment of the investigators.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Drug: Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
Outcomes
Primary Outcome Measures
objective response rate(ORR)
the total proportion of patients with complete response(CR or CRu)and partial response(PR)
Secondary Outcome Measures
Disease Control Rate (DCR)
the total proportion of patients with complete response(CR or CRu), partial response(PR)and Stable Disease(SD)
progression-free survival(PFS)
Time from treatment until disease progression or death
overall survival(OS)
Time from treatment until death from any cause
Full Information
NCT ID
NCT03410004
First Posted
January 12, 2018
Last Updated
January 23, 2018
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03410004
Brief Title
Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Official Title
Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2018 (Anticipated)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
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
Study of Chidamide as a single-agent treatment for patients with relapse or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)
Detailed Description
Chidamide,a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). Moreover, the aim was to study the correlation of clinical efficacy to mutation of certain genes as well.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Experimental
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Drug: Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Chidamide
Other Intervention Name(s)
Chidamide single agnet
Intervention Description
Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
Primary Outcome Measure Information:
Title
objective response rate(ORR)
Description
the total proportion of patients with complete response(CR or CRu)and partial response(PR)
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
the total proportion of patients with complete response(CR or CRu), partial response(PR)and Stable Disease(SD)
Time Frame
up to 2 years
Title
progression-free survival(PFS)
Description
Time from treatment until disease progression or death
Time Frame
2 years
Title
overall survival(OS)
Description
Time from treatment until death from any cause
Time Frame
2 years
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:
Diagnosed as Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) according to "2016 WHO classification of tumors of haematopoietic and lymphoid tissues";
Patients must have received systemic treatment (including chemotherapy or Hematopoietic stem cell transplantation), but did not achieve remission or had relapse after remission;
At least one measurable lesion;
Age 18-75 years, male or female;
ECOG performance status 0-1;
Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;.
Life expectancy no less than 3 months;
Not received chemotherapy, targeted medicine or stem cell transplantation 3 weeks before enrollment;
Patients have signed the Informed Consent Form.
Exclusion Criteria:
Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
Patients have undergone organ transplantation;
Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
Patients with active hemorrhage.
Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
Patients with active infection, or with continuous fever within 14 days prior to enrollment.
Had major organ surgery within 6 weeks prior to enrollment.
Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum).
Patients with mental disorders or those do not have the ability to consent.
Patients with drug abuse, long term alcoholism that may impact the results of the trial.
Patients who have central nervous system involvements;
Non-appropriate patients for the trial according to the judgment of the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuankai Shi, Dr.
Phone
010-67781331
Email
syuankai@cicams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shengyu Zhou, Dr.
Phone
010-67781331
Email
typhoonwho@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, Dr.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
We'll reach out to this number within 24 hrs