Extranodal NK/T-cell LymphomaPhase 2NCT03598959
Tofacitinib Combined With Chidamide in R/R ENKTCL
A Phase 2 study testing tofacitinib and chidamide in people with Extranodal NK/T-cell Lymphoma, run by Sichuan University at 1 site in China.
Trial summary
This study is to explore the efficacy and safety of tofacitinib combined with chidamide in patients with relapsed and refractory extranodal NK/T cell lymphoma. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma
- What is being tested?
- tofacitinib and chidamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2021
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Patients with primary refractory or recurrent extranodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.
- 2. Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL.
- 3. Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) </= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase </= 2 x upper limit of normal.
- 4.. Adequate cardiac function with left ventricular ejection fraction >/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- 5. Performance status 0-1. 6. Negative Beta diffusing capacity of lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
Who cannot join
- -1. Patients relapsed after allogeneic stem cell transplant 2. Patients with active hepatitis B or C(HBV DNA >/=10,000 copies/mL). 3. Active infection requiring parenteral antibiotics 4. HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts 5. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
- 6. Patients with a cQT longer than 500 ms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study of Safety and Efficacy of Tofacitinib Combined With Chidamide in Patients With Relapsed and Refractory Extranodal Natural Killer/T Cell Lymphoma
This study is to explore the efficacy and safety of tofacitinib combined with chidamide in patients with relapsed and refractory extranodal NK/T cell lymphoma.
- Conditions
- Extranodal NK/T-cell Lymphoma
- Being tested
- tofacitinib, chidamide
- 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.
tofacitinibDrug
orally 10 mg daily
chidamideDrug
orally 20 mg twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treated with tofacitinib and chidamide for 4 cycles. Receives: Drug: tofacitinib; Drug: chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression free survival
Measured: 2 years after recruitment
Secondary outcomes (3)
complete remission
Measured: 4 months after treatment
adverse events (AEs)
Measured: 2 years after recruitment
2-year overall survival
Measured: 2 years after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jan 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2021 (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 Extranodal NK/T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Ji, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598959
- Sponsor's protocol ID
- HXNKT 2.0
- Status last verified
- Jul 2018
- First submitted
- 16 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee S, Park HY, Kang SY, Kim SJ, Hwang J, Lee S, Kwak SH, Park KS, Yoo HY, Kim WS, Kim JI, Ko YH. Genetic alterations of JAK/STAT cascade and histone modification in extranodal NK/T-cell lymphoma nasal type. Oncotarget. 2015 Jul 10;6(19):17764-76. doi: 10.18632/oncotarget.3776.
PubMed 25980440
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Safety and Efficacy of Tofacitinib Combined With Chidamide in Patients With Relapsed and Refractory Extranodal Natural Killer/T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03598959
- Acronym / sponsor ID
- HXNKT 2.0
- Conditions
- Extranodal NK/T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Jul 2018 (actual)
- 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.
This study is to explore the efficacy and safety of tofacitinib combined with chidamide in patients with relapsed and refractory extranodal NK/T cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: tofacitinib, Drug: chidamideTreated with tofacitinib and chidamide for 4 cycles. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Patients with primary refractory or recurrent extranodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.
- 2. Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL.
- 3. Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) </= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase </= 2 x upper limit of normal.
- 4.. Adequate cardiac function with left ventricular ejection fraction >/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- 5. Performance status 0-1. 6. Negative Beta diffusing capacity of lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
Key exclusion criteria (2 listed)
- -1. Patients relapsed after allogeneic stem cell transplant 2. Patients with active hepatitis B or C(HBV DNA >/=10,000 copies/mL). 3. Active infection requiring parenteral antibiotics 4. HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts 5. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
- 6. Patients with a cQT longer than 500 ms
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 |
|---|---|---|
| tofacitiniborally 10 mg daily | Drug | Treatment |
| chidamideorally 20 mg twice weekly | Drug | Treatment |
Primary outcome
2-year progression free survival
Time frame: 2 years after recruitment
3 secondary outcomes
complete remission
Time frame: 4 months after treatment
adverse events (AEs)
Time frame: 2 years after recruitment
2-year overall survival
Time frame: 2 years after recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 25980440Lee S, Park HY, Kang SY, Kim SJ, Hwang J, Lee S, Kwak SH, Park KS, Yoo HY, Kim WS, Kim JI, Ko YH. Genetic alterations of JAK/STAT cascade and histone modification in extranodal NK/T-cell lymphoma nasal type. Oncotarget. 2015 Jul 10;6(19):17764-76. doi: 10.18632/oncotarget.3776.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tofacitinib and chidamide in people with Extranodal NK/T-cell Lymphoma, run by Sichuan University at 1 site in China.
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 5 inclusion and 2 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jie Ji, MD (86-28-85422373, jieji@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression free survival (time frame: 2 years after recruitment). 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 NCT03598959, 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 26 Jul 2018.