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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03629873

Collaborator

(none)

Enrollment

Location

46.9

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Large B-Cell, Diffuse Mantle Cell Lymphoma Peripheral T Cell Lymphoma Double-hit Lymphoma	Drug: Chidamide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

69 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

Progression-free survival rate [2 years after transplantation]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
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

Age 18-60 years, male and female
ECOG score 0-1
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
Expected survival ≥ 12 weeks
Volunteered to participate in this study and signed informed consent

Exclusion Criteria:

Have evidence of CNS lymphoma
Relapse after autologous hematopoietic stem cell transplantation
Active hepatitis B or hepatitis C virus infection
Severe active infection
HIV-infected persons
Liver cirrhosis or hepatic fibrosis
QTc > 500ms
Have mental disorder or unable to sign informed consent
History of drug abuse and intemperance
Women who are pregnant or lactating or have breeding intent
The investigators believe that any increase in the risk of the subject or interference with the results of the trial