Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma

NCT02944812 | Unknown Phase 2 DMC

• 1 other identifier: WYli-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• 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

Study Arms (1)

Chidamide

EXPERIMENTAL

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

Drug: Chidamide

Interventions

Chidamide 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.

Also known as: epidaza

Chidamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PTCL patients confirmed by histopathology examination.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong general hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Wenyu Li, Doctor

CONTACT

(+86)20-81884713-80412

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 26, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)