Clinical trial NCT02944812: Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma
Official title: Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma, a Single-Center, Nonrandomized Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral T Cell Lymphoma
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change of Chidamide concentration within the serum
timeFrame: 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.
measure: Change of Chidamide concentration within the cerebral-spinal fluid (CSF)
timeFrame: 5 minutes before the first dosage of Chidamide (0h) and 4 hours after the second dosage (4h) of Chidamide
Secondary outcomes:
measure: white blood cell count
timeFrame: 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
measure: red blood cell count
timeFrame: 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
measure: blood Hb level
timeFrame: 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
measure: blood platelet count
timeFrame: 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
measure: vital signs
timeFrame: 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
measure: Serum alanine aminotransferase level
timeFrame: 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
measure: Serum aspartate transaminase level
timeFrame: 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
measure: Serum total bilirubin level
timeFrame: 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
measure: Serum direct bilirubin level
timeFrame: 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
measure: Serum indirect bilirubin level
timeFrame: 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
measure: Serum glutamyltranspeptidase level
timeFrame: 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
measure: Serum albumin level
timeFrame: 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
measure: Serum ureal nitrogen level
timeFrame: 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
measure: Serum creatinin level
timeFrame: 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
measure: blood electrolytes level（K+, Na+，Cl-，Ca2+，Mg2+）
timeFrame: 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
measure: blood LDH level
timeFrame: 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
measure: QTc from ECG
timeFrame: 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
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong general hospital
state: Guangdong
Study officials:
References: