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

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ClinicalTrials.gov Identifier: NCT03273452
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Hongwei Xue, Qingdao University

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

Condition or disease Intervention/treatment Phase
Angioimmunoblastic T-cell Lymphoma Drug: Chidamide Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single arm trial, patients enrolled would be treated in this arm.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma, a Multicentric, Single Arm, Open Label Phase II Clinical Trial
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : May 2019


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 Name: PCT regimen



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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

  3. overall survival [ Time Frame: 24 months after the last patient's enrollment ]
    from the date of inclusion to date of death, irrespective of cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273452


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

Locations
China, Shandong
The Affiliated Hospital of Qingdao University Recruiting
Qingdao, Shandong, China, 266000
Contact: Hongwei Xue, MD. PhD    (+86)13475875599    Xuehongwei1867@163.com   
Sponsors and Collaborators
Qingdao University

Responsible Party: Hongwei Xue, MD., Qingdao University
ClinicalTrials.gov Identifier: NCT03273452     History of Changes
Other Study ID Numbers: Xuehw001
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the trial is finished, all the data would be available at the principle investigator's location.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Immunoblastic Lymphadenopathy
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphadenopathy
Prednisone
Etoposide phosphate
Etoposide
Thalidomide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents