Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong General Hospital; Guangdong Provincial People's Hospital

Criteria

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.