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Status unknownNCT03273452PETUpdated Sep 25, 2017

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

A Phase 2 interventional study of Chidamide in Angioimmunoblastic T-cell Lymphoma, sponsored by Qingdao University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-09-25.

Sponsored by Qingdao University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • DrugChidamide

    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

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What researchers measure

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).

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

Secondary outcomes

  1. duration of remission

    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

  2. progression free survival

    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

  3. overall survival

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

    Time frame: 24 months after the last patient's enrollment

06

Study locations

1 of 1 sites recruiting
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong 266000, China
    Recruiting
07

References and documents

Publications

  • 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. PubMed 35170082 ↗

Individual participant data

Plan to share: Yes — After the trial is finished, all the data would be available at the principle investigator's location.

Supporting information: Study protocol, Sap, Icf

08

Registry details

Key details

Study ID
NCT03273452
Lead sponsor
Qingdao University
Responsible party
Hongwei Xue (MD., Qingdao University) — Principal investigator
First posted
Sep 6, 2017
Start date
Mar 1, 2017
Primary completion
Feb 2019 (estimated)
Completion
May 2019 (estimated)
Last update
Sep 25, 2017

Study contacts

Hongwei Xue, MD. PhD
Contact
Xuehongwei1867@163.com
(+86)13475875599

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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