Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Peripheral T Cell Lymphoma

Intervention / Treatment
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* Drug: Chidamide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chidamide<br>Chidamide is given to the patients, the dosage is 30mg,biw,po. | Drug: Chidamide<br>* 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.<br>* Other names: epidaza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| 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 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 | 
| 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 |