Lymphoma, Extranodal NK-T-CellPhase 2NCT02878278
Differences Between Chidamide Taken Daily and Twice a Week in Therapeutic Effect，Pharmacokinetics, Pharmacodynamics and EB Virus Activation
A Phase 2 study testing Chidamide BIW and Chidamide QD in people with Lymphoma, Extranodal NK-T-Cell and EBV, run by Huiqiang Huang.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma, Extranodal NK-T-Cell, EBV
- What is being tested?
- Chidamide BIW and Chidamide QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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.
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- 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;
- Patients that had been enrolled in other clinical trials within 3 months prior to enrollment;
- Patients with drug abuse, long term alcoholism that may impact the results of the trial.
- Non-appropriate patients for the trial according to the judgment of the investigators.
Trial locations and contacts
No sites are listed yet.
Huiqiang Huang, Professor contact
About this study
Official title: Research About the Differences Between Chidamide Taken Daily and Twice a Week in Pharmacokinetics
- 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.
- To examine whether Chidamide could activate EB virus, and whether the above two different ways of administration are different in EB virus activation.
Read the detailed description
Currently, Chidamide is taken twice a week, this comes from cell experiment and phase I clinical trial, which showed that the de-acetylation effect of Chidamide could last for 72 hours after administration. However, daily administration of Chidamide may create a more steady Chidamide concentration, thus improve the de-acetylation effect of Chidamide, so it's necessary to compare the two different ways of administration.
Current study showed that Romidepsin, a HDACI, could activate EBV during the treatment of NKTCL, whether Chidamide, as a novel HDACI, could activate EBV is still not clear, so this problem is worth to be accessed.
- Conditions
- Lymphoma, Extranodal NK-T-Cell, EBV
- Being tested
- Chidamide BIW, Chidamide QD
- Keywords
- Chidamide, Administration method
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide BIWDrug
Also called Epidaza
Chidamide is given 30mg, twice a week
Chidamide QDDrug
Also called Epidaza
Chidamide is given 10mg,QD
| Study group | Role | What they receive |
|---|---|---|
| Chidamide BIW | Experimental | Chidamide is given 30mg,5mg/pill,twice a week, for at least 6 weeks Receives: Drug: Chidamide BIW |
| Chidamide QD | Experimental | Chidamide is given 10mg,5mg/pill, everyday,for at least 6 weeks. Receives: Drug: Chidamide QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Measured: through study completion, an average of 30 months
Duration of Response (DOR)
Measured: through study completion, an average of 30 months
Secondary outcomes (22)
Progression Free Survival (PFS)
Measured: through study completion, an average of 30 months
Overall Survival (OS)
Measured: through study completion, an average of 30 months
EBV-DNA
Measured: through study completion, an average of 30 months
EBV-antibodies
Measured: through study completion, an average of 30 months
white blood cell count
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
fasting blood glucose level
Measured: 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+）
Measured: 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
Measured: 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
QTc from ECG
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Extranodal NK-T-CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huiqiang Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huiqiang Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878278
- Sponsor's protocol ID
- Sunyat-senU201602101
- Status last verified
- Aug 2016
- First submitted
- 20 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The data of the trial would be accessable on the corresponding website after the trial is finished.
Publications
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.
PubMed 36740715
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research About the Differences Between Chidamide Taken Daily and Twice a Week in Pharmacokinetics
- ClinicalTrials.gov ID
- NCT02878278
- Acronym / sponsor ID
- Sunyat-senU201602101
- Conditions
- Lymphoma, Extranodal NK-T-Cell, EBV
- Keywords
- Chidamide, Administration method
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Huiqiang HuangUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- To examine whether Chidamide could activate EB virus, and whether the above two different ways of administration are different in EB virus activation.
Detailed description
Currently, Chidamide is taken twice a week, this comes from cell experiment and phase I clinical trial, which showed that the de-acetylation effect of Chidamide could last for 72 hours after administration. However, daily administration of Chidamide may create a more steady Chidamide concentration, thus improve the de-acetylation effect of Chidamide, so it's necessary to compare the two different ways of administration.
Current study showed that Romidepsin, a HDACI, could activate EBV during the treatment of NKTCL, whether Chidamide, as a novel HDACI, could activate EBV is still not clear, so this problem is worth to be accessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chidamide BIW | Experimental | Drug: Chidamide BIWChidamide is given 30mg,5mg/pill,twice a week, for at least 6 weeks |
| Chidamide QD | Experimental | Drug: Chidamide QDChidamide is given 10mg,5mg/pill, everyday,for at least 6 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chidamide BIWAlso: EpidazaChidamide is given 30mg, twice a week | Drug | Chidamide BIW |
| Chidamide QDAlso: EpidazaChidamide is given 10mg,QD | Drug | Chidamide QD |
Primary outcome
Overall Response Rate (ORR)
Time frame: through study completion, an average of 30 months
Duration of Response (DOR)
Time frame: through study completion, an average of 30 months
22 secondary outcomes
Progression Free Survival (PFS)
Time frame: through study completion, an average of 30 months
Overall Survival (OS)
Time frame: through study completion, an average of 30 months
EBV-DNA
Time frame: through study completion, an average of 30 months
EBV-antibodies
Time frame: through study completion, an average of 30 months
white blood cell count
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
fasting blood glucose level
Time frame: 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+）
Time frame: 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
Time frame: 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
QTc from ECG
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Derived from this study: PubMed 36740715Chen 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.
- Individual participant dataSharing planned: Yes. The data of the trial would be accessable on the corresponding website after the trial is finished.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiqiang Huang, Professor contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide BIW and Chidamide QD in people with Lymphoma, Extranodal NK-T-Cell and EBV, run by Huiqiang Huang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huiqiang Huang, Professor (huanghq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: through study completion, an average of 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02878278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.