Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients

August 30, 2018 updated by: Jun Zhu, Peking University

Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial

Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histopathology / cytology diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2016 classification criteria（NK/T cell lymphoma and ALK positive anaplastic large cell lymphoma excluded）including:Peripheral T-cell lymphoma, NOS，Angioimmunoblastic T-cell lymphoma，Anaplastic large-cell lymphoma, ALK negative，Enteropathy-associated T-cell lymphoma，Hepatosplenic T-cell lymphoma，Subcutaneous panniculitis T-cell lymphoma，Mycosis fungoides，Other T-cell lymphoma that investigators consider to be appropriate to be enrolled;
  2. Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD;
  3. Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci);
  4. Age 18-70 years, male or female;
  5. ECOG performance status 0-2;
  6. Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;
  7. ALT and serum creatinine <1.5 times of normal maximum;
  8. Life expectancy no less than 3 months;
  9. Willing to sign the Informed Consent Form.

Exclusion Criteria:

  1. NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma;
  2. Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures;
  3. QTc elongation with clinical significance ( male> 450ms, female> 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
  4. Patients have undergone organ transplantation;
  5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;
  6. Patients with active hemorrhage;
  7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;
  8. Patients with active infection or continuous fever within 14 days prior to enrollment;
  9. Had major organ surgery within 6 weeks prior to enrollment;
  10. Impaired liver function ( Total bilirubin > 1.5 times of normal maximum, ALT/AST> 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST> 5 times of normal maximum), impaired renal function (serum creatinine> 1.5 times of normal maximum);
  11. Patients with mental disorders or those do not have the ability to consent;
  12. Patients with drug abuse, long term alcoholism that may impact the results of the trial;
  13. Patients with invasion of central nervous system ;
  14. Non-appropriate patients for the trial according to the judgment of 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.
Drug: Chidamide
Chidamide 15mg orally BIW. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Other Names:
  • epidaza
Drug: Cyclophosphamide
Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Drug: Doxorubicin
Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Drug: Vincristine
Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Drug: Etoposide
Etoposide (100mg/m2) was administered intravenously on d1,2,3.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Drug: Prednisone
Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Experimental: Control group
Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.
Drug: Cyclophosphamide
Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Drug: Doxorubicin
Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Drug: Vincristine
Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Drug: Etoposide
Etoposide (100mg/m2) was administered intravenously on d1,2,3.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Drug: Prednisone
Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
complete remission (CR）rate
Time Frame: up to 2 years
The rate of patients who achieve complete remission after the treatment.
up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
objective response rate（ORR）
Time Frame: up to 2 years
The total proportion of patients with complete response（CR）and partial response（PR）.
up to 2 years
progression-free survival（PFS）
Time Frame: 2 years
Time from treatment until disease progression or death.
2 years
overall survival（OS）
Time Frame: 2 years after the last patient's enrollment.
From the date of inclusion to date of death, irrespective of any cause.
2 years after the last patient's enrollment.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University International Hospital
Jiangxi Provincial Cancer Hospital
Shandong Tumor Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSIIT-T13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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