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

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)

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

Study Overview

• Status: Unknown
• Conditions: Peripheral T-cell Lymphoma
• Intervention / Treatment: Drug: Chidamide; Drug: prednisone; Drug: Cyclophosphamide; Drug: etoposide; Drug: Methotrexate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhiming Li, MD; Phone Number: 86-20-87343765; Email: lizhm@sysucc.org.cn
• Study Contact Backup: Name: Yu Wang, MD; Phone Number: 86-20-87343349; Email: wangyu@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Department of Medical Oncology,Sun Yat-Sen University Cancer Center
      • Contact: Zhiming Li, DM; Phone Number: +86-13719189172; Email: Lizhm@sysucc.org.cn
      • Contact: Yu Wang, DM; Phone Number: 86-20-87343765; Email: Wangyu@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination therapy regimen; Chidamide + prednisone+cyclophosphamide+etoposide+methotrexate	Drug: Chidamide; Oral, each taking 30 mg (6 tablets), medication twice a week, 30 minutes after breakfast; Drug: prednisone; oral, 20mg / day,after breakfast; Drug: Cyclophosphamide; oral, 50mg / day,after lunch; Drug: etoposide; oral, 50mg / day,after dinner; Drug: Methotrexate; oral, 10mg / times, once a week,after breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Progress Free Survival(PFS)	Time from treatment until disease progression or death	2 years
Overall Survival	Time from treatment until death from any cause	2 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Wenqi Jiang, MD, Department of Medical Oncology,Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: February 18, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 23, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: relapsed or refractory; Combination therapy; peripheral T-cell lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Cyclophosphamide; Etoposide; Prednisone; Methotrexate
• Other Study ID Numbers: 2016-FXY-079-内科

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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