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Chidamide Combined With PECM in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Primary Purpose

Peripheral T-cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide
prednisone
Cyclophosphamide
etoposide
Methotrexate
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphoma focused on measuring relapsed or refractory, peripheral T-cell lymphoma, Combination therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histopathologically confirmed peripheral T-cell lymphoma (PTCL) patients;
  2. Patients who have had at least one systemic treatment (including chemotherapy, hematopoietic stem cell transplantation, etc.) who have not remission or relapsed after remission;
  3. For various reasons can not be hematopoietic stem cell transplantation in patients;
  4. The age of 18-75 years old, male, female open;
  5. ECOG (Eastern Cooperative Oncology Group) physical scoring 0-1 points;
  6. Absolute value of neutrophil≥1.5 × 109 / L, platelet≥90 × 109 / L, hemoglobin≥90g / L;
  7. The expected survival time ≥ 3 months;
  8. No radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation were performed within 4 weeks prior to enrollment.
  9. Voluntary signature of written informed consent.

Exclusion Criteria:

  1. Pregnancy, breastfeeding women and unwilling to take contraceptive measures of reproductive age patients;
  2. B-mode ultrasonography showed that the width of end-diastolic pericardial dark area was ≥10mm;
  3. Patients receiving organ transplants;
  4. Patients receiving symptomatic treatment of pre-bone marrow toxicity within 7 days prior to enrollment;
  5. Patients with active bleeding;
  6. Liver function abnormalities (total bilirubin> 1.5 times the upper limit of normal, ALT( alanine aminotransferase) / AST (Aspartate aminotransferase)> 2.5 times the upper limit of normal or hepatic involvement of ALT / AST> 5 times the upper limit of normal), renal dysfunction Creatinine> 1.5 times the upper limit of normal), electrolyte abnormalities;
  7. Persons with mental disabilities / those who can not obtain informed consent;
  8. Patients with drug abuse and long-term alcohol abuse that may affect the evaluation of test results;
  9. The investigators determined that they were not fit to participate in the trial.

Sites / Locations

  • Department of Medical Oncology,Sun Yat-Sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination therapy regimen

Arm Description

Chidamide + prednisone+cyclophosphamide+etoposide+methotrexate

Outcomes

Primary Outcome Measures

Objective response rate
the total proportion of patients with complete response（CR or CRu）and partial response（PR）

Secondary Outcome Measures

Duration of response
Duration of complete response（CR or CRu）and partial response（PR）
Progress Free Survival(PFS)
Time from treatment until disease progression or death
Overall Survival
Time from treatment until death from any cause

Full Information

First Posted
February 18, 2017
Last Updated
October 23, 2017
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03321890
Brief Title
Chidamide Combined With PECM in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Official Title
A Multicenter, Single-arm, Open II Phase Clinical Trial Evaluating the Efficacy of Chidamide Combined With Prednisone, Cyclophosphamide, Etoposide, and Methotrexate (PECM) in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To observe the efficacy and safety of Chidamide combined with prednisone, cyclophosphamide, etoposide and methotrexate in relapsed or refractory PTCL.
Detailed Description
Prednisone, cyclophosphamide, etoposide, and methotrexate regimens are derived from a "metronidazole, etoposide, procarbazine and cyclophosphamide (PEPC) regimen" regimen that differs from the traditional "maximal Tolerance "chemotherapy, and the use of low-dose chemotherapy, frequent drug therapy, the purpose is to anti-angiogenesis and reduce drug resistance. At present, the program in our treatment of relapsed or refractory PTCL patients effective, safe and controllable, but also look forward to other joint treatment, so as to achieve better curative effect. To provide new treatment options for such patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-cell Lymphoma
Keywords
relapsed or refractory, peripheral T-cell lymphoma, Combination therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination therapy regimen
Arm Type
Experimental
Arm Description
Chidamide + prednisone+cyclophosphamide+etoposide+methotrexate
Intervention Type
Drug
Intervention Name(s)
Chidamide
Intervention Description
Oral, each taking 30 mg (6 tablets), medication twice a week, 30 minutes after breakfast
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
oral, 20mg / day,after breakfast
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
oral, 50mg / day,after lunch
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
oral, 50mg / day,after dinner
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
oral, 10mg / times, once a week,after breakfast
Primary Outcome Measure Information:
Title
Objective response rate
Description
the total proportion of patients with complete response（CR or CRu）and partial response（PR）
Time Frame
every 8 weeks until 2 years after last patient's enrollment
Secondary Outcome Measure Information:
Title
Duration of response
Description
Duration of complete response（CR or CRu）and partial response（PR）
Time Frame
every 8 weeks until 2 years after last patient's enrollment
Title
Progress Free Survival(PFS)
Description
Time from treatment until disease progression or death
Time Frame
2 years
Title
Overall Survival
Description
Time from treatment until death from any cause
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histopathologically confirmed peripheral T-cell lymphoma (PTCL) patients; Patients who have had at least one systemic treatment (including chemotherapy, hematopoietic stem cell transplantation, etc.) who have not remission or relapsed after remission; For various reasons can not be hematopoietic stem cell transplantation in patients; The age of 18-75 years old, male, female open; ECOG (Eastern Cooperative Oncology Group) physical scoring 0-1 points; Absolute value of neutrophil≥1.5 × 109 / L, platelet≥90 × 109 / L, hemoglobin≥90g / L; The expected survival time ≥ 3 months; No radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation were performed within 4 weeks prior to enrollment. Voluntary signature of written informed consent. Exclusion Criteria: Pregnancy, breastfeeding women and unwilling to take contraceptive measures of reproductive age patients; B-mode ultrasonography showed that the width of end-diastolic pericardial dark area was ≥10mm; Patients receiving organ transplants; Patients receiving symptomatic treatment of pre-bone marrow toxicity within 7 days prior to enrollment; Patients with active bleeding; Liver function abnormalities (total bilirubin> 1.5 times the upper limit of normal, ALT( alanine aminotransferase) / AST (Aspartate aminotransferase)> 2.5 times the upper limit of normal or hepatic involvement of ALT / AST> 5 times the upper limit of normal), renal dysfunction Creatinine> 1.5 times the upper limit of normal), electrolyte abnormalities; Persons with mental disabilities / those who can not obtain informed consent; Patients with drug abuse and long-term alcohol abuse that may affect the evaluation of test results; The investigators determined that they were not fit to participate in the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiming Li, MD
Phone
86-20-87343765
Email
lizhm@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang, MD
Phone
86-20-87343349
Email
wangyu@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenqi Jiang, MD
Organizational Affiliation
Department of Medical Oncology,Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Oncology,Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiming Li, DM
Phone
+86-13719189172
Email
Lizhm@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Yu Wang, DM
Phone
86-20-87343765
Email
Wangyu@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Chidamide Combined With PECM in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

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