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

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Treatments: Carmustine; Cyclophosphamide; Cytarabine; Etoposide

Criteria

Inclusion Criteria:

1. Aggressive lymphoma subjects: diffuse large B cell lymphoma confirmed by immunohistochemistry and aaIPI≥3; double-hit lymphoma, as first-line or 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