Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients

NCT03617432 | Unknown Phase 2

• 1 other identifier: CSIIT-T13
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial

Conditions

Experimental Tumor

Outcome Measures

Primary Outcomes (1)

• complete remission (CR）rate

  The rate of patients who achieve complete remission after the treatment.

  up to 2 years

Secondary Outcomes (3)

• objective response rate（ORR）

  up to 2 years

• progression-free survival（PFS）

  2 years

• overall survival（OS）

  2 years after the last patient's enrollment.

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.

Drug: Chidamide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Etoposide; Drug: Prednisone

Control group

EXPERIMENTAL

Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.

Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Etoposide; Drug: Prednisone

Interventions

Chidamide DRUG

Chidamide 15mg orally BIW. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

Also known as: epidaza

Experimental group

Cyclophosphamide DRUG

Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

Control group; Experimental group

Doxorubicin DRUG

Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

Control group; Experimental group

Vincristine DRUG

Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

Control group; Experimental group

Etoposide DRUG

Etoposide (100mg/m2) was administered intravenously on d1,2,3.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

Control group; Experimental group

Prednisone DRUG

Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathology / cytology diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2016 classification criteria（NK/T cell lymphoma and ALK positive anaplastic large cell lymphoma excluded）including:Peripheral T-cell lymphoma, NOS，Angioimmunoblastic T-cell lymphoma，Anaplastic large-cell lymphoma, ALK negative，Enteropathy-associated T-cell lymphoma，Hepatosplenic T-cell lymphoma，Subcutaneous panniculitis T-cell lymphoma，Mycosis fungoides，Other T-cell lymphoma that investigators consider to be appropriate to be enrolled;
• Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD;
• Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci);
• Age 18-70 years, male or female;
• ECOG performance status 0-2;
• Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;
• ALT and serum creatinine \<1.5 times of normal maximum;
• Life expectancy no less than 3 months;
• Willing to sign the Informed Consent Form.

You may not qualify if:

• NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma;
• Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures;
• QTc elongation with clinical significance ( male\> 450ms, female\> 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
• Patients have undergone organ transplantation;
• Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;
• Patients with active hemorrhage;
• Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;
• Patients with active infection or continuous fever within 14 days prior to enrollment;
• Had major organ surgery within 6 weeks prior to enrollment;
• Impaired liver function ( Total bilirubin \> 1.5 times of normal maximum, ALT/AST\> 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST\> 5 times of normal maximum), impaired renal function (serum creatinine\> 1.5 times of normal maximum);
• Patients with mental disorders or those do not have the ability to consent;
• Patients with drug abuse, long term alcoholism that may impact the results of the trial;
• Patients with invasion of central nervous system ;
• Non-appropriate patients for the trial according to the judgment of the investigators.

Sponsors & Collaborators

• Peking University: lead
• Peking University International Hospital: collaborator
• Shandong Tumor Hospital: collaborator
• Jiangxi Provincial Cancer Hospital: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Neoplasms, Experimental

Interventions

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

Condition Hierarchy (Ancestors)

Neoplasms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Central Study Contacts

Jun Zhu, Dr.

CONTACT

010-88140650; dreaming2217@hotmai.com

Yuqin Song, Dr.

CONTACT

010-88140650; songyuqin622@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of lymphoma department

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 6, 2018
• Study Start: August 28, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2022
• Last Updated: September 4, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)