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Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma

Primary Purpose

Peripheral T Cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T Cell Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. PTCL patients confirmed by histopathology examination.
  2. Did not accept radiotherapy, chemotherapy, targeted-therapy or hematopoietic stem cell transplantation within 4 weeks prior to inclusion;
  3. Age 18-75 years old, male or female;
  4. ECOG: 0-1 point;
  5. Body weight: male 67±20 kilograms (47-87 kg), female 55±20 kilograms (35-75 kg);
  6. Blood-routine test should satisfy (except lymphoma-related abnormalities): Hb≥90g/L，ANC≥1.5×109/L，PLT≥90×109/L；
  7. Estimated survival ≥ 3 months;
  8. Willing to sign the written consent before the trial.

Exclusion Criteria:

  1. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
  2. QTc elongation with clinical significance (˃ 480ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment.
  3. Cardiac B ultrasound show end-diastolic pericardial dark zone≥ 10mm
  4. Patients who have received 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 with 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 creatinin˃ 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.

Sites / Locations

  • Guangdong general hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chidamide

Arm Description

Chidamide is given to the patients, the dosage is 30mg,biw,po.

Outcomes

Primary Outcome Measures

Change of Chidamide concentration within the serum
Change of Chidamide concentration within the cerebral-spinal fluid (CSF)

Secondary Outcome Measures

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
blood electrolytes level（K+, Na+，Cl-，Ca2+，Mg2+）
blood LDH level
QTc from ECG

Full Information

First Posted
October 21, 2016
Last Updated
October 24, 2016
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02944812
Brief Title
Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma
Official Title
Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma, a Single-Center, Nonrandomized Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial intends: 1.To evaluate the concentration of Chidamide in the serum and cerebral-spinal fluid of PTCL patients at certain time points after taking the medicine, to evaluate the pharmacokinetics of Chidamide in these patients and its CNS (central nervous system) distribution. 2. To evaluate the efficiency and safety of Chidamide in PTCL patients.

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
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chidamide
Arm Type
Experimental
Arm Description
Chidamide is given to the patients, the dosage is 30mg,biw,po.
Intervention Type
Drug
Intervention Name(s)
Chidamide
Other Intervention Name(s)
epidaza
Intervention Description
Chidamide is given to the patients as described, and drug concentration is measured in patients' serum and CSF, also, parameters concerning efficacy and safety are also obtained.
Primary Outcome Measure Information:
Title
Change of Chidamide concentration within the serum
Time Frame
5 minutes before taking Chidamide (0h) and 1h, 2h, 4h, 8h and 12h after taking Chidamide (1h，2h，4h，8h，12h), assessed up to 1 week from date of enrollment.
Title
Change of Chidamide concentration within the cerebral-spinal fluid (CSF)
Time Frame
5 minutes before the first dosage of Chidamide (0h) and 4 hours after the second dosage (4h) of Chidamide
Secondary Outcome Measure Information:
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
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 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
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: PTCL patients confirmed by histopathology examination. Did not accept radiotherapy, chemotherapy, targeted-therapy or hematopoietic stem cell transplantation within 4 weeks prior to inclusion; Age 18-75 years old, male or female; ECOG: 0-1 point; Body weight: male 67±20 kilograms (47-87 kg), female 55±20 kilograms (35-75 kg); Blood-routine test should satisfy (except lymphoma-related abnormalities): Hb≥90g/L，ANC≥1.5×109/L，PLT≥90×109/L； Estimated survival ≥ 3 months; Willing to sign the written consent before the trial. Exclusion Criteria: Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures. QTc elongation with clinical significance (˃ 480ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment. Cardiac B ultrasound show end-diastolic pericardial dark zone≥ 10mm 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenyu Li, Doctor
Phone
(+86)20-81884713-80412
Facility Information:
Facility Name
Guangdong general hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyu Li, MD PhD
Phone
+86 20 81884713-80412

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data of the trial would be available on the corresponding website after the trial has been finished.

Learn more about this trial

Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma

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