Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma (PET: Prednisone, Etoposide and Thalidomide)

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to investigate the efficacy and safety of PET regimen combined with Chidamide for angioimmunoblastic T cell lymphoma patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qingdao University
• Treatments: Etoposide; Etoposide phosphate; Prednisone; Thalidomide

Criteria

Inclusion Criteria:

1. Pathologically diagnosed as angioimmunoblastic T cell lymphoma (diagnosed by pathologic department in IIIA hospitals or verified by certified institutions), immunohistochemistry should include: CD3, CD4, CD8, CD20, CD10, CD21, CD35, Bcl6, CXCL13, EBER, PD-1, Ki67.

2. At least on measurable focus (≥1.0*1.0cm by imaging), or at least one evaluable focus;

3. Age 18-75 years, both male and female;

4. ECOG 0-2, KPS≥ 70points;

5. Expected survival ≥3 months;

6. Peripheral blood neutrophil count ≥1.5×10^9/L, platelet count≥ 75×10^9/L, Hb≥ 90g/L;

7. Liver function: bilirubin ≤1.5 times of the normal maximum; AST、ALT≤2 times of the normal maximum (for patients with liver infiltration AST、ALT≤3 times of the normal maximum); renal function: blood creatinine ≤2 times the normal maximum;

8. Negative random pregnancy test for fertile women patients within 7 days before enrollment;

9. No radiation therapy, chemotherapy, targeted therapy nor hemopoietic stem cell transplantation within 4 weeks before enrollment;

10. No anti-tumor therapy at enrollment, including herbal therapy, immunotherapy and biologic therapy, symptomatic treatment is not within this range;

Exclusion Criteria:

1. Women during pregnancy or lactation, and fertile women that are not willing to take contraceptive measurements;

2. Patients with other malignant tumors simultaneously that have not been effectively controlled;

3. Patients with history of using HDAC inhibitors;

4. Patients who are allergic to medicine used in the trial, or have metabolic disorders toward these medicine;

5. Patients with severe active infection;

6. Patients with HIV or syphilis infection;

7. Patients with prolonged QT interval (male > 450ms，female > 470ms), or chronic heart failure patients with level III or IV cardiac function; or those have the following heart disease within 6 months before enrollment: acute coronary syndrome, acute heart failure (heart function level III or IV), distinctive ventricular arrhythmias (prolonged ventricular tachycardia, ventricular fibrillation, etc);

8. Patients with history of organ transplantation;

9. Patients with history of thrombosis and embolism;

10. Patients with mental disorders or those who are unable to sign a written consent;

11. Patients with drug abuse or long-time alcoholism that may influence the result of the trial;

12. Patients who do not have capacity of legal transactions;

13. Patients currently in other clinical trials;

14. Those who are recognized as inappropriate for the trial by the investigators;