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Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma) (CHOP)

This study is currently recruiting participants.
Verified August 2017 by The First Affiliated Hospital of Soochow University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03268889
First Posted: August 31, 2017
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University
  Purpose
This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients.

Condition Intervention
Peripheral T Cell Lymphoma Drug: Chidamide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chidamide With Cyclophosphamide, Etoposide, Vincristine and Prednisone for de Novo Peripheral T Cell Lymphoma Patients

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Soochow University:

Primary Outcome Measures:
  • Complete Remission Rate [ Time Frame: every 3 months until 30 months after the last patient's enrollment ]
    the rate of patients who achieve complete remission after the treatment


Secondary Outcome Measures:
  • progression free survival [ Time Frame: from the day of treatment to the date of first documented progression,up to 30 months after the last patient's enrollment ]
    from date of inclusion to date of progression, relapse, or death from any cause

  • duration of remission [ Time Frame: from the day of treatment to the date of first documented progression,up to 30 months after the last patient's enrollment ]
    from date of complete remission to date of progression, relapse, or death from any cause

  • overall survival [ Time Frame: 30 months after the last patient's enrollment ]
    from the date of inclusion to date of death, irrespective of cause

  • adverse events [ Time Frame: from the date of first cycle of treatment to 30 months after last patient's enrollment ]
    any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure


Estimated Enrollment: 39
Actual Study Start Date: June 15, 2017
Estimated Study Completion Date: September 15, 2020
Estimated Primary Completion Date: June 15, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment group
In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone.
Drug: Chidamide
Chidamide is given to the patients in this study along with CHOP regimen, to access the efficacy and safety in this cohort of PTCL patients. The dosage of the above regimen is as follows: Chidamide, 30mg,po,biw; Cyclophosphamide 750mg/m2, ivgtt, d1; Epirubicin 70mg/ m2, ivgtt, d1; Vincristine 3mg/ m2, ivgtt, d1; Prednisone 100mg/ m2, po, d1-5.
Other Name: CHOP regimen

Detailed Description:
After enrollment, patients in this study will be given Chidamide, Cyclophosphamide, Epirubicin, Vincristine and Prednisone, and the efficacy and safety of this regimen are then evaluated.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2008 classification criteria(NK/T cell lymphoma, ALK positive anaplastic large cell lymphoma and granuloma fungoides excluded);
  2. De novo peripheral T cell lymphoma patients;
  3. Age 18-70 years old;
  4. ECOG≤2;
  5. Female patients not in lactation nor pregnancy, and no intention to concept during the study and 12 months thereafter. Male patients agree not to impregnate his partner during the study and 12 months thereafter;
  6. The patient should have evaluable foci (lymphnodes with diameter≥1.0cm, or evaluable skin foci);
  7. Willing to sign a written consent.

Exclusion Criteria:

  1. T lymphoblast lymphoma;
  2. Bone marrow infiltrated with lymphoma cell ≥25%;
  3. NT/T cell lymphoma;
  4. Granuloma fungoides;
  5. Severe impaired liver/ renal function (ALT, Bilirubin or creatinine >3 times the normal maximum);
  6. Uncontrolled infection;
  7. Organic cardiopathy with clinical manifestation or impaired cardiac function (NYHA ≥ level 2);
  8. With other tumors;
  9. With other condition that cause the patient unable to sign the written consent;
  Contacts and Locations
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): NCT03268889


Contacts
Contact: Zhengming Jin, MD,PhD (+86)512-65223637 suzhouhematology@163.com

Locations
China, Jiangsu
the First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Zhengming Jin, MD, PhD    (+86)512-67781856      
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Investigators
Principal Investigator: Zhengming Jin, MD,PhD The First Affiliated Hospital of Soochow University
  More Information

Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT03268889     History of Changes
Other Study ID Numbers: Jinzm 001
First Submitted: August 30, 2017
First Posted: August 31, 2017
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All the data would be available at the First Affiliated Hospital after the study is finished
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: From the time of study finish
URL: http://

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

Keywords provided by The First Affiliated Hospital of Soochow University:
Chidamide, CHOP regimen

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Prednisone
Etoposide
Vincristine
Doxorubicin
Prednisolone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal