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

NCT ID: NCT03629873

Last Updated: 2022-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2021-12-31

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Carmustine; Etoposide; Cytarabine; Cyclophosphamide; Autologous hematopoeitic stem cell transplantation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

WEI XU

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hematological Department, People's Hospital of Jiangsu Province

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

JSPH-Chi-BEAC-HSCT

Identifier Type: -

Identifier Source: org_study_id