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

Mantle Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03629873
• Other study ID #: JSPH-Chi-BEAC-HSCT
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2021
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 69
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Hematological Department, People's Hospital of Jiangsu Province	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival rate		2 years after transplantation
Secondary	Overall survival		2 years after transplantation
Secondary	Complete remission		3 months after transplantation
Secondary	Time of hematopoietic reconstitution		15 days, 1 month
Secondary	Non-relapse mortality		2 years