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

Phase 2

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

• Registration Number: NCT03629873
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-08-05
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-14
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-30
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression-free survival rate	2 years after transplantation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hematological Department, People's Hospital of Jiangsu Province; 🇨🇳 Nanjing, Jiangsu, China