Back to resultsChidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma
Primary Purpose
Peripheral T Cell Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Chidamide with ICE regimen
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral T Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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.
- There is at least 1 focus that could be evaluated both by histopathology and cytology (˃1.5cm) according to Cheson criteria.
- 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.
- Age18-75 years, male or female;
- General condition should be ECOG 0-1.
- Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;
- Expected survival ≥ 3 months;
- No radiotherapy, chemotherapy, targeted therapy or hemopoietic stem cell transplantation received within 4 weeks prior to enrollment.
- Willing to sign the written consent.
Exclusion Criteria:
- Women during pregnancy or lactation, or fertile women 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 who have received 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 with 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 creatinin˃ 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.
- Non-appropriate patients for the trial according to the judgment of the investigators.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chidamide with ICE regimen
Arm Description
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.
Outcomes
Primary Outcome Measures
Objective remission rate
Secondary Outcome Measures
Duration of remission
progress free survival
overall survival
white blood cell count
red blood cell count
blood Hb level
blood platelet count
vital signs
Serum alanine aminotransferase level
Serum aspartate transaminase level
Serum total bilirubin level
Serum direct bilirubin level
Serum indirect bilirubin level
Serum glutamyltranspeptidase level
Serum albumin level
Serum ureal nitrogen level
Serum creatinin level
fasting blood glucose level
blood electrolytes level（K+, Na+，Cl-，Ca2+，Mg2+）
blood LDH level
QTc from ECG
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02856997
Brief Title
Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma
Official Title
Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma: A Phase II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuankai Shi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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:
The type, incidence, severity of incidents related to the use of the regimen.
Laboratory abnormalities, including the type, incidence, severity, relationship with the use of the regimen.
Incidence of level 3-4 incidents and laboratory abnormalities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chidamide with ICE regimen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chidamide with ICE regimen
Other Intervention Name(s)
Epidaza，HBI-8000
Intervention Description
Chidamide and ICE regimen, dosage described in arm description
Primary Outcome Measure Information:
Title
Objective remission rate
Time Frame
through study completion, an average of 30 months
Secondary Outcome Measure Information:
Title
Duration of remission
Time Frame
through study completion, an average of 30 months
Title
progress free survival
Time Frame
through study completion, an average of 30 months
Title
overall survival
Time Frame
through study completion, an average of 30 months
Title
white blood cell count
Time Frame
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
Title
red blood cell count
Time Frame
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
Title
blood Hb level
Time Frame
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
Title
blood platelet count
Time Frame
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
Title
vital signs
Time Frame
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
Title
Serum alanine aminotransferase level
Time Frame
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
Title
Serum aspartate transaminase level
Time Frame
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
Title
Serum total bilirubin level
Time Frame
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
Title
Serum direct bilirubin level
Time Frame
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
Title
Serum indirect bilirubin level
Time Frame
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
Title
Serum glutamyltranspeptidase level
Time Frame
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
Title
Serum albumin level
Time Frame
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
Title
Serum ureal nitrogen level
Time Frame
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
Title
Serum creatinin level
Time Frame
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
Title
fasting blood glucose level
Time Frame
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
Title
blood electrolytes level（K+, Na+，Cl-，Ca2+，Mg2+）
Time Frame
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
Title
blood LDH level
Time Frame
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
Title
QTc from ECG
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
There is at least 1 focus that could be evaluated both by histopathology and cytology (˃1.5cm) according to Cheson criteria.
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.
Age18-75 years, male or female;
General condition should be ECOG 0-1.
Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;
Expected survival ≥ 3 months;
No radiotherapy, chemotherapy, targeted therapy or hemopoietic stem cell transplantation received within 4 weeks prior to enrollment.
Willing to sign the written consent.
Exclusion Criteria:
Women during pregnancy or lactation, or fertile women 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 who have received 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 with 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 creatinin˃ 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.
Non-appropriate patients for the trial according to the judgment of the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuankai Shi, Doctor
Phone
86-15821531560
Email
drshiyuankai@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
the data of the trial would be open to the public after the trial is finished
Learn more about this trial
Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma
We'll reach out to this number within 24 hrs