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

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Cyclophosphamide; Etoposide; Etoposide phosphate; Methotrexate; Prednisone

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.