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

NCT03273452 | Unknown Phase 2

• 1 other identifier: Xuehw001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Angioimmunoblastic T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• duration of remission

  from the day of remission to the date of first documented progression，up to 24 months after the last patient's enrollment

• progression free survival

  from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment

• overall survival

  24 months after the last patient's enrollment

Study Arms (1)

treatment group

EXPERIMENTAL

In this group, patients will be given prednisone 100mg,qd,d1-5; etoposide 100mg,qd,d1-5; thalidomide 100mg,qn,d1-14; Chidamide 30mg,biw;

Drug: Chidamide

Interventions

Chidamide DRUG

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;)

Also known as: PCT regimen

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35170082 DERIVED

MeSH Terms

Conditions

Immunoblastic Lymphadenopathy

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphadenopathy; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Hongwei Xue, MD. PhD

CONTACT

(+86)13475875599; Xuehongwei1867@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Model Details: single arm trial, patients enrolled would be treated in this arm.

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 6, 2017
• Study Start: March 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)