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

Primary Purpose

Angioimmunoblastic T-cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Chidamide

About this trial

This is an interventional treatment trial for Angioimmunoblastic T-cell Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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;

Sites / Locations

The Affiliated Hospital of Qingdao UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment group

Arm Description

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;

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

duration of remission

from date of complete remission to date of progression, relapse, or death from any cause

progression free survival

from date of inclusion to date of progression, relapse, or death from any cause

overall survival

from the date of inclusion to date of death, irrespective of cause

Full Information

NCT ID

NCT03273452

First Posted

August 31, 2017

Last Updated

September 20, 2017

Sponsor

Qingdao University

1. Study Identification

Unique Protocol Identification Number

NCT03273452

Brief Title

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

Acronym

PET

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

February 2019 (Anticipated)

Study Completion Date

May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Qingdao University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angioimmunoblastic T-cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment group

Arm Type

Experimental

Arm Description

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;

Intervention Type

Drug

Intervention Name(s)

Chidamide

Other Intervention Name(s)

PCT regimen

Intervention Description

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;)

Primary Outcome Measure Information:

Title

Objective remission rate(ORR)

Description

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).

Time Frame

every 3 months until 24 months after the last patient's enrollment

Secondary Outcome Measure Information:

Title

duration of remission

Description

from date of complete remission to date of progression, relapse, or death from any cause

Time Frame

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

Title

progression free survival

Description

from date of inclusion to date of progression, relapse, or death from any cause

Time Frame

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

Title

overall survival

Description

from the date of inclusion to date of death, irrespective of cause

Time Frame

24 months after the last patient's enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hongwei Xue, MD. PhD

Phone

(+86)13475875599

Xuehongwei1867@163.com

Facility Information:

Facility Name

The Affiliated Hospital of Qingdao University

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hongwei Xue, MD. PhD

Phone

(+86)13475875599

Xuehongwei1867@163.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

After the trial is finished, all the data would be available at the principle investigator's location.

Citations:

PubMed Identifier

35170082

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.

Results Reference

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

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