Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma

NCT ID: NCT02944812

Last Updated: 2016-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-01-31

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.

Conditions

Peripheral T Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chidamide

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

Group Type: EXPERIMENTAL

Chidamide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

epidaza

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wenyu Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangdong general hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenyu Li, Doctor

Role: CONTACT

Phone: (+86)20-81884713-80412

Facility Contacts

Wenyu Li, MD PhD

Role: primary

Other Identifiers

WYli-002

Identifier Type: -

Identifier Source: org_study_id