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

Peripheral T-cell Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03321890
• Other study ID #: 2016-FXY-079-??
• Status: Recruiting
• Phase: Phase 2
• First received: February 18, 2017
• Last updated: October 23, 2017
• Start date: March 7, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2017
• Source: Sun Yat-sen University
• Contact: Zhiming Li, MD
• Phone: 86-20-87343765
• Email: lizhm[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To observe the efficacy and safety of Chidamide combined with prednisone, cyclophosphamide, etoposide and methotrexate in relapsed or refractory PTCL.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 31, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Intervention

Drug:
• Chidamide
Oral, each taking 30 mg (6 tablets), medication twice a week, 30 minutes after breakfast
• prednisone
oral, 20mg / day,after breakfast
• Cyclophosphamide
oral, 50mg / day,after lunch
• etoposide
oral, 50mg / day,after dinner
• Methotrexate
oral, 10mg / times, once a week,after breakfast

Locations

Country	Name	City	State
China	Department of Medical Oncology,Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	the total proportion of patients with complete response(CR or CRu)and partial response(PR)	every 8 weeks until 2 years after last patient's enrollment
Secondary	Duration of response	Duration of complete response(CR or CRu)and partial response(PR)	every 8 weeks until 2 years after last patient's enrollment
Secondary	Progress Free Survival(PFS)	Time from treatment until disease progression or death	2 years
Secondary	Overall Survival	Time from treatment until death from any cause	2 years