Clinical trial NCT03273452: Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma (PET: Prednisone, Etoposide and Thalidomide)
Official title: Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma, a Multicentric, Single Arm, Open Label Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Angioimmunoblastic T-cell Lymphoma
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm trial, patients enrolled would be treated in this arm.
Primary purpose: TREATMENT

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 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;

Primary outcomes:
measure: Objective remission rate(ORR)
timeFrame: every 3 months until 24 months after the last patient's enrollment
Secondary outcomes:
measure: duration of remission
timeFrame: from the day of remission to the date of first documented progression，up to 24 months after the last patient's enrollment
measure: progression free survival
timeFrame: from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment
measure: overall survival
timeFrame: 24 months after the last patient's enrollment
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
References:
citation: Wang Y, Zhang M, Song W, Cai Q, Zhang L, Sun X, Zou L, Zhang H, Wang L, Xue H. Chidamide plus prednisone, etoposide, and thalidomide for untreated angioimmunoblastic T-cell lymphoma in a Chinese population: A multicenter phase II trial. Am J Hematol. 2022 May;97(5):623-629. doi: 10.1002/ajh.26499. Epub 2022 Mar 11.