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

Nanjing Medical University

Status and phase: Unknown; Phase 2

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

Treatments: Drug: Chidamide

Study type: Interventional

Funder types: Other

Identifiers

NCT03629873

JSPH-Chi-BEAC-HSCT

Details and patient eligibility

About

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

Enrollment: 69 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)