Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects

Study Overview
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Brief Summary
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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

Official Title
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A Phase 2 Study Evaluating Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects

Conditions
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Lymphoma, Large B-Cell, Diffuse, Mantle Cell Lymphoma, Peripheral T Cell Lymphoma, Double-hit Lymphoma

Intervention / Treatment
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* Drug: Chidamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Chidamide|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival rate |  | 2 years after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years after transplantation | 
| Complete remission |  | 3 months after transplantation | 
| Time of hematopoietic reconstitution |  | 15 days, 1 month | 
| Non-relapse mortality |  | 2 years |