Double-hit Lymphoma, Lymphoma, Large B-Cell, Diffuse, Mantle Cell Lymphoma, Peripheral T Cell Lymphoma
Conditions
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
Interventions
DRUGChidamide
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
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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 3. Age 18-60 years, male and female 4. ECOG score 0-1 5. 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 6. Expected survival ≥ 12 weeks 7. Volunteered to participate in this study and signed informed consent
Exclusion criteria
1. Have evidence of CNS lymphoma 2. Relapse after autologous hematopoietic stem cell transplantation 3. Active hepatitis B or hepatitis C virus infection 4. Severe active infection 5. HIV-infected persons 6. Liver cirrhosis or hepatic fibrosis 7. QTc \> 500ms 8. Have mental disorder or unable to sign informed consent 9. History of drug abuse and intemperance 10. Women who are pregnant or lactating or have breeding intent 11. The investigators believe that any increase in the risk of the subject or interference with the results of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate | 2 years after transplantation |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed