Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma

Peripheral T Cell Lymphoma Clinical Trial

Official title:

Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma, a Single-Center, Nonrandomized Phase II Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02944812
• Other study ID #: WYli-002
• 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma

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