Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Primary Purpose
B-cell Non-Hodgkin's Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Chidamide plus DICE Regimen
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Non-Hodgkin's Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Diagnosed as B-cell Non-Hodgkin's Lymphoma (NHL) according to "2008 WHO classification of tumors of haematopoietic and lymphoid tissues", including Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, transformed indolent lymphoma, and other subtypes that investigators consider to be appropriate to be enrolled;
- Patients must have received at least one systemic treatment (including chemotherapy), but did not achieve remission or had relapse after remission;
- At least one measurable lesion;
- Age18-65 years, male or female; ECOG performance status 0-1;
- Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥100 × 109/L, Hb ≥ 90g/L;.
- Life expectancy no less than 3 months;
- Not received chemotherapy, targeted medicine or stem cell transplantation 4 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 history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
- Patients with active infection, or with continuous fever within 14 days prior to enrollment.
- Patients with active infection of HBV, HCV or HIV;
- 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
Chidamide plus DICE regimen
Arm Description
Chidamide combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) regimen
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
progression-free survival(PFS)
Time from treatment until disease progression or death
events-free survival(EFS)
Time from treatment to disease progression, death, or discontinuation of treatment for any reason
overall survival(OS)
Time from treatment until death from any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03105596
Brief Title
Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Official Title
Study of Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 11, 2017 (Anticipated)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking 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
This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
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 combined with DICE in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Non-Hodgkin's 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
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chidamide plus DICE regimen
Arm Type
Experimental
Arm Description
Chidamide combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) regimen
Intervention Type
Drug
Intervention Name(s)
Chidamide plus DICE Regimen
Intervention Description
Chidamide 20mg orally d1, 4, 8, 11, 15, 18; Dexamethasone 10mg,ivg, d1-4; ifosfamide 1g/m2, ivg, d1-4, given over 4 hours; Mesna 0.4g, 0,4,8,12 hours during Ifosfamide transfusion, ivg, d1-4; Cisplatin 25mg/m2, ivg, d1-4; Etoposide 60mg/m2, ivg. d1-4.
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
every 6 weeks until 2 years
Secondary Outcome Measure Information:
Title
progression-free survival(PFS)
Description
Time from treatment until disease progression or death
Time Frame
2 years
Title
events-free survival(EFS)
Description
Time from treatment to disease progression, death, or discontinuation of treatment for any reason
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
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed as B-cell Non-Hodgkin's Lymphoma (NHL) according to "2008 WHO classification of tumors of haematopoietic and lymphoid tissues", including Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, transformed indolent lymphoma, and other subtypes that investigators consider to be appropriate to be enrolled;
Patients must have received at least one systemic treatment (including chemotherapy), but did not achieve remission or had relapse after remission;
At least one measurable lesion;
Age18-65 years, male or female; ECOG performance status 0-1;
Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥100 × 109/L, Hb ≥ 90g/L;.
Life expectancy no less than 3 months;
Not received chemotherapy, targeted medicine or stem cell transplantation 4 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 history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
Patients with active infection, or with continuous fever within 14 days prior to enrollment.
Patients with active infection of HBV, HCV or HIV;
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
Jun Zhu, MD
Phone
+86-10-88196596
Email
zj@bjcancer.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhu, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
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