Back to resultsEfficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects
Primary Purpose
Lymphoma, Large B-Cell, Diffuse, Mantle Cell Lymphoma, Peripheral T Cell Lymphoma
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse
Eligibility Criteria
Inclusion Criteria:
- Aggressive lymphoma subjects: diffuse large B cell lymphoma confirmed by immunohistochemistry, aaIPI≥2 or double-hit lymphoma, as first-line consolidation; diffuse large B cell lymphoma as second-line consolidation therapy; peripheral T-cell lymphoma except ALK-positive type, as first-line or second-line consolidation therapy; mantle cell lymphoma, as first-line or second-line consolidation therapy.
Adequate organ system function including:
Creatinine clearance rate ≥ 80ml/min and creatinine < 160μmol/L ALT/AST ≤ 2 upper limit of normal Total Bilirubin < 2 upper limit of normal FEV1、FVC and DLCO ≥ 50% predictive value Left ventricular ejection fraction ≥ 50% No Symptomatic arrhythmia
- Age 18-60 years, male and female
- ECOG score 0-1
- Number of neutrophil ≥ 1.5×10^9/L, number of platelet ≥ 70×10^9/L, concentration of hemoglobin ≥ 90g/L, number of CD34+ cells ≥ 2.0×10^6/kg
- Expected survival ≥ 12 weeks
- Volunteered to participate in this study and signed informed consent
Exclusion Criteria:
- Have evidence of CNS lymphoma
- Relapse after autologous hematopoietic stem cell transplantation
- Active hepatitis B or hepatitis C virus infection
- Severe active infection
- HIV-infected persons
- Liver cirrhosis or hepatic fibrosis
- QTc > 500ms
- Have mental disorder or unable to sign informed consent
- History of drug abuse and intemperance
- Women who are pregnant or lactating or have breeding intent
- The investigators believe that any increase in the risk of the subject or interference with the results of the trial
Sites / Locations
- Hematological Department, People's Hospital of Jiangsu Province
Outcomes
Primary Outcome Measures
Progression-free survival rate
Secondary Outcome Measures
Overall survival
Complete remission
Time of hematopoietic reconstitution
Non-relapse mortality
Full Information
NCT ID
NCT03629873
First Posted
August 5, 2018
Last Updated
December 30, 2021
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03629873
Brief Title
Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects
Official Title
A Phase 2 Study Evaluating Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a single arm, multi-center, open study to evaluating efficacy and safety of Chi-BEAC combining with auto-HSCT to treat aggressive lymphoma Subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse, Mantle Cell Lymphoma, Peripheral T Cell Lymphoma, Double-hit 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
69 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Chidamide
Other Intervention Name(s)
Carmustine, Etoposide, Cytarabine, Cyclophosphamide, Autologous hematopoeitic stem cell transplantation
Intervention Description
Chidamide 30mg po d-7、-4、0、3; Carmustine 300mg/m^2 IVD d-6; Etoposide 150mg/m^2/d qd IVD d-5~-2; Cytarabine 150mg/m^2 q12h IVD d-5~-2; Cyclophosphamide 1.0g/m^2/d qd IVD d-5~-2
Primary Outcome Measure Information:
Title
Progression-free survival rate
Time Frame
2 years after transplantation
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
2 years after transplantation
Title
Complete remission
Time Frame
3 months after transplantation
Title
Time of hematopoietic reconstitution
Time Frame
15 days, 1 month
Title
Non-relapse mortality
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aggressive lymphoma subjects: diffuse large B cell lymphoma confirmed by immunohistochemistry, aaIPI≥2 or double-hit lymphoma, as first-line consolidation; diffuse large B cell lymphoma as second-line consolidation therapy; peripheral T-cell lymphoma except ALK-positive type, as first-line or second-line consolidation therapy; mantle cell lymphoma, as first-line or second-line consolidation therapy.
Adequate organ system function including:
Creatinine clearance rate ≥ 80ml/min and creatinine < 160μmol/L ALT/AST ≤ 2 upper limit of normal Total Bilirubin < 2 upper limit of normal FEV1、FVC and DLCO ≥ 50% predictive value Left ventricular ejection fraction ≥ 50% No Symptomatic arrhythmia
Age 18-60 years, male and female
ECOG score 0-1
Number of neutrophil ≥ 1.5×10^9/L, number of platelet ≥ 70×10^9/L, concentration of hemoglobin ≥ 90g/L, number of CD34+ cells ≥ 2.0×10^6/kg
Expected survival ≥ 12 weeks
Volunteered to participate in this study and signed informed consent
Exclusion Criteria:
Have evidence of CNS lymphoma
Relapse after autologous hematopoietic stem cell transplantation
Active hepatitis B or hepatitis C virus infection
Severe active infection
HIV-infected persons
Liver cirrhosis or hepatic fibrosis
QTc > 500ms
Have mental disorder or unable to sign informed consent
History of drug abuse and intemperance
Women who are pregnant or lactating or have breeding intent
The investigators believe that any increase in the risk of the subject or interference with the results of the trial
Facility Information:
Facility Name
Hematological Department, People's Hospital of Jiangsu Province
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects
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