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

NCT ID: NCT03321890

Last Updated: 2017-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-07
• Study Completion Date: 2020-12-31

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.

Conditions

Peripheral T-cell Lymphoma

Keywords

relapsed or refractory; peripheral T-cell lymphoma; Combination therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination therapy regimen

Chidamide + prednisone+cyclophosphamide+etoposide+methotrexate

Group Type: EXPERIMENTAL

Chidamide

Intervention Type: DRUG

Oral, each taking 30 mg (6 tablets), medication twice a week, 30 minutes after breakfast

prednisone

Intervention Type: DRUG

oral, 20mg / day,after breakfast

Cyclophosphamide

Intervention Type: DRUG

oral, 50mg / day,after lunch

etoposide

Intervention Type: DRUG

oral, 50mg / day,after dinner

Methotrexate

Intervention Type: DRUG

oral, 10mg / times, once a week,after breakfast

Interventions

Chidamide

Oral, each taking 30 mg (6 tablets), medication twice a week, 30 minutes after breakfast

Intervention Type: DRUG

prednisone

oral, 20mg / day,after breakfast

Intervention Type: DRUG

Cyclophosphamide

oral, 50mg / day,after lunch

Intervention Type: DRUG

etoposide

oral, 50mg / day,after dinner

Intervention Type: DRUG

Methotrexate

oral, 10mg / times, once a week,after breakfast

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li Zhiming

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenqi Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Oncology,Sun Yat-Sen University

Locations

Department of Medical Oncology,Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiming Li, MD

Role: CONTACT

Phone: 86-20-87343765

Email: lizhm@sysucc.org.cn

Yu Wang, MD

Role: CONTACT

Phone: 86-20-87343349

Email: wangyu@sysucc.org.cn

Facility Contacts

Zhiming Li, DM

Role: primary

Yu Wang, DM

Role: backup

Other Identifiers

2016-FXY-079-内科

Identifier Type: -

Identifier Source: org_study_id