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

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

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

Study Overview

• Status: Unknown
• Conditions: Experimental Tumor
• Intervention / Treatment: Drug: Chidamide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Etoposide; Drug: Prednisone

Detailed Description

Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients.

• Study Type: Interventional
• Enrollment (Anticipated): 114
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100142
    • Recruiting
    • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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;
2. Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD;
3. Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci);
4. Age 18-70 years, male or female;
5. ECOG performance status 0-2;
6. Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;
7. ALT and serum creatinine <1.5 times of normal maximum;
8. Life expectancy no less than 3 months;
9. Willing to sign the Informed Consent Form.

Exclusion Criteria:

1. NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma;
2. Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures;
3. 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;
4. Patients have undergone organ transplantation;
5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;
6. Patients with active hemorrhage;
7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;
8. Patients with active infection or continuous fever within 14 days prior to enrollment;
9. Had major organ surgery within 6 weeks prior to enrollment;
10. 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);
11. Patients with mental disorders or those do not have the ability to consent;
12. Patients with drug abuse, long term alcoholism that may impact the results of the trial;
13. Patients with invasion of central nervous system ;
14. Non-appropriate patients for the trial according to the judgment of the investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.	Drug: Chidamide; Chidamide 15mg orally BIW. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.; Other Names: epidaza; Drug: Cyclophosphamide; Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.; Drug: Doxorubicin; Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.; Drug: Vincristine; Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.; Drug: Etoposide; 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.; Drug: Prednisone; Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Experimental: Control group; Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.	Drug: Cyclophosphamide; Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.; Drug: Doxorubicin; Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.; Drug: Vincristine; Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.; Drug: Etoposide; 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.; Drug: Prednisone; Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete remission (CR）rate	The rate of patients who achieve complete remission after the treatment.	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate（ORR）	The total proportion of patients with complete response（CR）and partial response（PR）.	up to 2 years
progression-free survival（PFS）	Time from treatment until disease progression or death.	2 years
overall survival（OS）	From the date of inclusion to date of death, irrespective of any cause.	2 years after the last patient's enrollment.

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Peking University International Hospital; Jiangxi Provincial Cancer Hospital; Shandong Tumor Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• 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; Neoplasms, Experimental; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; 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; Antibiotics, Antineoplastic; Cyclophosphamide; Etoposide; Prednisone; Doxorubicin; Vincristine
• Other Study ID Numbers: CSIIT-T13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No