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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02944812
Other study ID # WYli-002
Secondary ID
Status Recruiting
Phase Phase 2
First received October 21, 2016
Last updated October 24, 2016
Start date March 2016
Est. completion date January 2019

Study information

Verified date October 2016
Source Guangdong General Hospital
Contact Wenyu Li, Doctor
Phone (+86)20-81884713-80412
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Chidamide
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.

Locations

Country Name City State
China Guangdong general hospital Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Chidamide concentration within the serum 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. No
Primary Change of Chidamide concentration within the cerebral-spinal fluid (CSF) 5 minutes before the first dosage of Chidamide (0h) and 4 hours after the second dosage (4h) of Chidamide No
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary blood LDH 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 Yes
Secondary 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 Yes
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