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

NCT03321890 | Unknown Phase 2 DMC

• 1 other identifier: 2016-FXY-079-内科
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral T-cell Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Duration of response

  every 8 weeks until 2 years after last patient's enrollment

• Progress Free Survival(PFS)

  2 years

• Overall Survival

  2 years

Study Arms (1)

Combination therapy regimen

EXPERIMENTAL

Chidamide + prednisone+cyclophosphamide+etoposide+methotrexate

Drug: Chidamide; Drug: prednisone; Drug: Cyclophosphamide; Drug: etoposide; Drug: Methotrexate

Interventions

Chidamide DRUG

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

Combination therapy regimen

prednisone DRUG

oral, 20mg / day,after breakfast

Combination therapy regimen

Cyclophosphamide DRUG

oral, 50mg / day,after lunch

Combination therapy regimen

etoposide DRUG

oral, 50mg / day,after dinner

Combination therapy regimen

Methotrexate DRUG

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

Combination therapy regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Recurrence

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Prednisone; Cyclophosphamide; Etoposide; Methotrexate

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Glucosides; Glycosides; Carbohydrates; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wenqi Jiang, MD

  Department of Medical Oncology,Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiming Li, MD

CONTACT

86-20-87343765; lizhm@sysucc.org.cn

Yu Wang, MD

CONTACT

86-20-87343349; wangyu@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: October 26, 2017
• Study Start: March 7, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2020
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

CN (1)