Status:
UNKNOWN
Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma (PET: Prednisone, Etoposide and Thalidomide)
Lead Sponsor:
Qingdao University
Conditions:
Angioimmunoblastic T-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study aims to investigate the efficacy and safety of PET regimen combined with Chidamide for angioimmunoblastic T cell lymphoma patients.
Detailed Description
Patients enrolled in the trial would be given prednisone, etoposide, thalidomide and Chidamide, and the response and side effects are observed and documented.
Eligibility Criteria
Inclusion
- 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.
- At least on measurable focus (≥1.0\*1.0cm by imaging), or at least one evaluable focus;
- Age 18-75 years, both male and female;
- ECOG 0-2, KPS≥ 70points;
- Expected survival ≥3 months;
- Peripheral blood neutrophil count ≥1.5×10\^9/L, platelet count≥ 75×10\^9/L, Hb≥ 90g/L;
- 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;
- Negative random pregnancy test for fertile women patients within 7 days before enrollment;
- No radiation therapy, chemotherapy, targeted therapy nor hemopoietic stem cell transplantation within 4 weeks before enrollment;
- No anti-tumor therapy at enrollment, including herbal therapy, immunotherapy and biologic therapy, symptomatic treatment is not within this range;
Exclusion
- Women during pregnancy or lactation, and fertile women that are not willing to take contraceptive measurements;
- Patients with other malignant tumors simultaneously that have not been effectively controlled;
- Patients with history of using HDAC inhibitors;
- Patients who are allergic to medicine used in the trial, or have metabolic disorders toward these medicine;
- Patients with severe active infection;
- Patients with HIV or syphilis infection;
- 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);
- Patients with history of organ transplantation;
- Patients with history of thrombosis and embolism;
- Patients with mental disorders or those who are unable to sign a written consent;
- Patients with drug abuse or long-time alcoholism that may influence the result of the trial;
- Patients who do not have capacity of legal transactions;
- Patients currently in other clinical trials;
- Those who are recognized as inappropriate for the trial by the investigators;
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03273452
Start Date
March 1 2017
End Date
May 1 2019
Last Update
September 25 2017
Active Locations (1)
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1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000