Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma

Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma: A Phase II Clinical Trial

The purpose of this study is to evaluate the efficacy and safety of Chidamide with ICE regimen in patients with relapsed/refractory Peripheral T Cell lymphoma.

Study Overview

• Status: Unknown
• Conditions: Peripheral T Cell Lymphoma
• Intervention / Treatment: Drug: Chidamide with ICE regimen

Detailed Description

Efficacy of the combined regimen is evaluated primarily by objective remission rate, including complete remission, unverified complete remission and partial remission, also by duration of remission, progression free survival, and overall survival.

Safety is accessed by:

1. The type, incidence, severity of incidents related to the use of the regimen.
2. Laboratory abnormalities, including the type, incidence, severity, relationship with the use of the regimen.
3. Incidence of level 3-4 incidents and laboratory abnormalities.

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 2

Contacts and Locations

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. Patients with Peripheral T Cell Lymphoma (PTCL) verified by histopathology/ cytology, according to WHO 2008 classification criteria, including: adult T cell lymphoma or leukemia (human T cell leukemia virus 1 positive); angioimmunoblastic t cell lymphoma; ALK positive anaplastic large cell lymphoma; ALK negative anaplastic large cell lymphoma; non-specified peripheral T cell lymphoma; extra-nodal NK/T cell lymphoma; bowl disease related T cell lymphoma; hepatosplenic T cell lymphoma; subcutaneous panniculitis-like T cell lymphoma; allergic mycosis fungoides.
2. There is at least 1 focus that could be evaluated both by histopathology and cytology (˃1.5cm) according to Cheson criteria.
3. The patients should have had at least 1 course of systemic treatment (including chemo-therapy, stem cell transplantation etc), but did not achieve remission or had relapse after remission.
4. Age18-75 years, male or female;
5. General condition should be ECOG 0-1.
6. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;
7. Expected survival ≥ 3 months;
8. No radiotherapy, chemotherapy, targeted therapy or hemopoietic stem cell transplantation received within 4 weeks prior to enrollment.
9. Willing to sign the written consent.

Exclusion Criteria:

1. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
2. 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.
3. Patients who have received organ transplantation.
4. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
5. Patients with active hemorrhage.
6. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
7. Patients with active infection, or with continuous fever within 14 days prior to enrollment.
8. Had major organ surgery within 6 weeks prior to enrollment.
9. 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 creatinin˃ 1.5 times of normal maximum).
10. Patients with mental disorders or those do not have the ability to consent.
11. Patients with drug abuse, long term alcoholism that may impact the results of the trial.
12. 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Chidamide with ICE regimen; Drugs:Chidamide and ICE regimen (ifosfamide, Mesna,Carboplatin and etoposide): Chidamide 20mg on d1,4,8,11;ifosfamide 1.2g/ m2，d1-4,ivg during 4 hours; Mesna 0.4g, 0,4,8 hours during Ifosfamide transfusion, ivg, d1-4; Carboplatin AUC=4, d2,ivg; etoposide 65mg/m 2, d1-4, ivg. 3 weeks as 1 course, for 6 courses. if the effect is PR or better than PR, go to auto-stem cell transplantation, no further treatment with Chidamide is needed. If the effect is PR or better than PR and no auto-stem cell transplantation available,Chidamide 20mg orally, twice every week, till the end of the trial.

Drug: Chidamide with ICE regimen; Chidamide and ICE regimen, dosage described in arm description; Other Names: Epidaza，HBI-8000

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective remission rate	through study completion, an average of 30 months

Secondary Outcome Measures

Outcome Measure	Time Frame
white blood cell count	every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
red blood cell count	every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
blood Hb level	every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
blood platelet count	every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
vital signs	every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum alanine aminotransferase level	every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum aspartate transaminase level	every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum total bilirubin level	every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum direct bilirubin level	every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum indirect bilirubin level	every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum glutamyltranspeptidase level	every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum albumin level	every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum ureal nitrogen level	every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum creatinin level	every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
fasting blood glucose level	every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
blood electrolytes level（K+, Na+，Cl-，Ca2+，Mg2+）	every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
blood LDH level	every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
QTc from ECG	every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Duration of remission	through study completion, an average of 30 months
progress free survival	through study completion, an average of 30 months
overall survival	through study completion, an average of 30 months

Collaborators and Investigators

• Sponsor: Yuankai Shi

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: July 24, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Estimate): August 5, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: July 1, 2016

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
• Other Study ID Numbers: CancerIHCAMS 16-059/1138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the data of the trial would be open to the public after the trial is finished