Differences Between Chidamide Taken Daily and Twice a Week in Therapeutic Effect，Pharmacokinetics, Pharmacodynamics and EB Virus Activation

NCT02878278 | Unknown Phase 2 DMC

• 1 other identifier: Sunyat-senU201602101
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To compare the therapeutic effects, safety and the corresponding pharmacokinetics and pharmacodynamics between two different method of drug administration: 10mg, daily and 30mg/d, twice every week, and find out the more effect way of Chidamide administration.
2. 2.To examine whether Chidamide could activate EB virus, and whether the above two different ways of administration are different in EB virus activation.

Conditions

Lymphoma, Extranodal NK-T-Cell; EBV

Keywords

Chidamide; Administration method

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR)

  through study completion, an average of 30 months

• Duration of Response (DOR)

  through study completion, an average of 30 months

Secondary Outcomes (22)

• Progression Free Survival (PFS)

  through study completion, an average of 30 months

• Overall Survival (OS)

  through study completion, an average of 30 months

• EBV-DNA

  through study completion, an average of 30 months

• EBV-antibodies

  through study completion, an average of 30 months

• 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

Study Arms (2)

Chidamide BIW

EXPERIMENTAL

Chidamide is given 30mg,5mg/pill,twice a week, for at least 6 weeks

Drug: Chidamide BIW

Chidamide QD

EXPERIMENTAL

Chidamide is given 10mg,5mg/pill, everyday,for at least 6 weeks.

Drug: Chidamide QD

Interventions

Chidamide BIW DRUG

Chidamide is given 30mg, twice a week

Also known as: Epidaza

Chidamide BIW

Chidamide QD DRUG

Chidamide is given 10mg,QD

Also known as: Epidaza

Chidamide QD

Eligibility Criteria

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

You may qualify if:

• NKTCL patients confirmed by histopathology examination.
• Age 18-75 years old, male or female, fertile women should have effective contraceptive measures.
• NT/T cell lymphoma patients with disease progression or non-remission after L-asparaginase treatment or L-asparaginase-contained regimen treatment. Non-remission is defined as: patients do not have partial remission (PR) or better responses after treated by L-asparaginase contained regimen.
• Patients who had 1-3 regimens (including chemotherapy, stem cell transplantation), but did not achieve remission or relapsed after remission.
• With at least 1 measurable focus, whose long diameter ˃ 1.5cm, short diameter ˃1.0cm, or at least one evaluable focus.
• Body weight: male 67±20 kilograms (47-87 kg), female 55±20 kilograms (35-75 kg);
• Blood-routine test within 14 days of enrollment should satisfy (except lymphoma-related abnormalities): Hb≥80g/L，ANC≥1.0×109/L，PLT≥75×109/L；
• ECOG: 0-2;
• 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 ( male˃ 450ms, female˃ 470ms), 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≥ 10cm
• 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.
• Abnormal blood routine test results within 14 days prior to enrollment (Hb˂80g/L，ANC˂1.0×109/L，PLT˂75×109/L； 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 history of Chidamide treatment and had disease progression within 6 months afterward;
• Patients that received large dose of steroids (˃10mg/d dexamethasone or other steroids of the equivalent dosage) within 4 weeks prior to enrollment;
• Patients with hemophagocytic syndrome;
• Patients with central nerve system diseases or history of central nerve system diseases;
• Patients with mental disorders or those do not have the ability to consent;

Sponsors & Collaborators

• Huiqiang Huang: lead

Related Publications (1)

• Chen J, Zuo Z, Gao Y, Yao X, Guan P, Wang Y, Li Z, Liu Z, Hong JH, Deng P, Chan JY, Cheah DMZ, Lim J, Chai KXY, Chia BKH, Pang JWL, Koh J, Huang D, He H, Sun Y, Liu L, Liu S, Huang Y, Wang X, You H, Saraf SA, Grigoropoulos NF, Li X, Bei J, Kang T, Lim ST, Teh BT, Huang H, Ong CK, Tan J. Aberrant JAK-STAT signaling-mediated chromatin remodeling impairs the sensitivity of NK/T-cell lymphoma to chidamide. Clin Epigenetics. 2023 Feb 6;15(1):19. doi: 10.1186/s13148-023-01436-6.

  PMID: 36740715 DERIVED

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Huiqiang Huang, Professor

CONTACT

huanghq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 20, 2016
• First Posted: August 25, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 25, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share