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

September 20, 2017 updated by: Hongwei Xue, Qingdao University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
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
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;)
Other Names:
  • PCT regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective remission rate(ORR)
Time Frame: every 3 months until 24 months after the last patient's enrollment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of remission
Time Frame: from the day of remission to the date of first documented progression，up to 24 months after the last patient's enrollment
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
progression free survival
Time Frame: from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment
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
overall survival
Time Frame: 24 months after the last patient's enrollment
from the date of inclusion to date of death, irrespective of cause
24 months after the last patient's enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

September 5, 2017

First Posted (Actual)

September 6, 2017

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xuehw001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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