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

Angioimmunoblastic T-cell Lymphoma Clinical Trial

— PET  

Official title:

Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma, a Multicentric, Single Arm, Open Label Phase II Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03273452
• Other study ID #: Xuehw001
• Status: Recruiting
• Phase: Phase 2
• First received: August 31, 2017
• Last updated: September 20, 2017
• Start date: March 1, 2017
• Est. completion date: May 2019

Study information

• Verified date: September 2017
• Source: Qingdao University
• Contact: Hongwei Xue, MD. PhD
• Phone: (+86)13475875599
• Email: Xuehongwei1867[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Patients enrolled in the trial would be given prednisone, etoposide, thalidomide and Chidamide, and the response and side effects are observed and documented.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Angioimmunoblastic T-cell Lymphoma
• Lymphoma
• Lymphoma, T-Cell

Intervention

Drug:
• Chidamide
Chidamide will be given orally 30mg,biw, along with PET regimen (prednisone 100mg,po,qd,d1-5; etoposide 100mg,po,qd,d1-5; thalidomide 100mg,po,qn,d1-14;)

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective remission rate(ORR)	the rate of patients who achieve objective remission after the treatment,including CR (complete remission),CRu (complete remission with unrecovered platelet count) and PR (partial remission).	every 3 months until 24 months after the last patient's enrollment
Secondary	duration of remission	from date of complete remission to date of progression, relapse, or death from any cause	from the day of remission to the date of first documented progression,up to 24 months after the last patient's enrollment
Secondary	progression free survival	from date of inclusion to date of progression, relapse, or death from any cause	from the day of treatment to the date of first documented progression,up to 24 months after the last patient's enrollment
Secondary	overall survival	from the date of inclusion to date of death, irrespective of cause	24 months after the last patient's enrollment