Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma
Study Details
Study Description
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.
- To evaluate the efficiency and safety of Chidamide in PTCL patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Chidamide Chidamide is given to the patients, the dosage is 30mg,biw,po. |
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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;
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Age 18-75 years old, male or female;
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ECOG: 0-1 point;
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Body weight: male 67±20 kilograms (47-87 kg), female 55±20 kilograms (35-75 kg);
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Blood-routine test should satisfy (except lymphoma-related abnormalities): Hb≥90g/L，ANC≥1.5×109/L，PLT≥90×109/L；
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Estimated survival ≥ 3 months;
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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.
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Cardiac B ultrasound show end-diastolic pericardial dark zone≥ 10mm
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Patients who have received organ transplantation.
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Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
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Patients with active hemorrhage.
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Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
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Patients with active infection, or with continuous fever within 14 days prior to enrollment.
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Had major organ surgery within 6 weeks prior to enrollment.
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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).
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guangdong general hospital | Guangzhou | Guangdong | China | 510080 |
Sponsors and Collaborators
- Guangdong Provincial People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WYli-002