NKTCLPhase 1/2SelinexorNCT06559553
"Selinexor+Pegaspargase+Dexamethasone"in Ⅰ/Ⅱ NKTCL
A Phase 1/2 study testing Selinexor+pegaspargase+dexamethasone in people with NKTCL and Selinexor, run by Mingzhi Zhang at 1 site in China.
Trial summary
evaluate the efficacy and safety of "Selinexor+pegaspargase+dexamethasone" in early stage NK/ T-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Selinexor+pegaspargase+dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old, ECOG score 0-2; (including those aged 18 and 70);
- Pre-survival time \> 6 months;
- The pathological tissue was confirmed as NK/T cell lymphoma (the pathological report of the first three months of enrollment could be accepted) (Note: If there is any doubt about the pathological diagnosis, domestic third-party consultation could be organized);
- Clinical stage Ⅰ to Ⅱ (CA stage) with at least one measurable lesion;
- Acceptable hematological indicators, no contraindications to chemotherapy; Neutrophil absolute value ≥1.0×10^9 /L, platelet ≥75×10^9 /L, hemoglobin ≥80g/L (except patients with lymphoma bone marrow infiltration);
- Liver function: direct bilirubin ≤1.5× upper limit reference value; Glutamic pyruvic transaminase or glutamic oxalacetic transaminase ≤2.5× upper limit reference value; Alkaline phosphatase ≤3×ULN in non-bone invaded patients;
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- Renal function: serum creatinine ≤1.5×ULN;
- Female and male patients of reproductive age and their spouses are willing to use adequate contraception throughout the study period, and female patients of reproductive age must have a negative serum pregnancy test within 7 days before the first dose;
- The newly treated patient had not received other tumor-related treatment in the past;
- Subjects voluntarily participate in the clinical trial, sign informed consent, and cooperate with follow-up;
Who cannot join
- Refuse to collect blood samples;
- Previous allergy to any of the drugs in the program;
- Pregnant and lactating women;
- Major diseases that the investigator believes can cause interference with the test;
- Combined with other tumors;
- There are contraindications related to therapeutic drugs in the program;
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- Persons with serious mental illness;
- Participating in other clinical trials;
- Previous anti-tumor therapy (such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy);
- Other serious medical conditions that may limit participants\' participation in the trial, such as uncontrolled diabetes; Severe cardiac insufficiency (NYHA grade II or above); Acute coronary syndrome within the last 6 months; Coronary revascularization such as stenting, coronary artery bypass surgery, and other heart and large vessel related procedures within the last 6 months; Severe arrhythmias include frequent ventricular early, ventricular tachycardia, rapid atrial fibrillation/flutter, and severe bradycardia. Uncontrolled hypertension: systolic blood pressure \>150mmHg, diastolic blood pressure \>100mmHg. Gastric ulcers (stomach ulcers that researchers have determined are at risk of perforation); Active autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren\'s syndrome, autoimmune thrombocytopenia, etc.); Severe respiratory disease (such as obstructive pulmonary disease and a history of bronchospasm);
- Hemophagic cell syndrome;
- Researchers do not consider it suitable for inclusion;
- Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) antibody positive; Syphilis test positive.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Oncology Department of The First Affilliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Zhang Mingzhi Mingzhi Zhang, Pro,Dr, +8613838565629, Mingzhi_zhang@126.com
About this study
Official title: A Prospective Clinical Study of "Selinexor+Pegaspargase+Dexamethasone" in the Treatment of Stage Ⅰ/Ⅱ NK/ T-Cell Lymphoma
evaluate the efficacy and safety of "Selinexor+pegaspargase+dexamethasone" in early stage NK/ T-cell lymphoma
Read the detailed description
Patients with early NK/T cell lymphoma were treated with an oral regimen of \"Selinisol + pemaspartase + dexamethasone\"
- Being tested
- Selinexor+pegaspargase+dexamethasone
- Keywords
- NKTCL, Selinexor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selinexor+pegaspargase+dexamethasoneDrug
Nuclear export protein-1 is the main transporter protein for leucine-rich proteins to enter the cytoplasm from the nucleus through the nuclear pore complex, which is overexpressed in malignant tumor cells. Studies have shown that Selinexor inhibits the nuclear export of viral mRNA such as EBV, and has good therapeutic potential for NKTCL. Selinexor combined with pemaspartase, dexamethasone and sequential radiotherapy may be the golden choice for early NK/T cell lymphoma, improving the local control rate of the disease and improving the overall prognosis of NK/T cell lymphoma.
| Study group | Role | What they receive |
|---|---|---|
| Selinexor+pegaspargase+dexamethasone | Experimental | Nuclear export protein-1 is the main transporter protein for leucine-rich proteins to enter the cytoplasm from the nucleus through the nuclear pore complex, which is overexpressed in malignant tumor cells. Studies have shown that Selinexor inhibits the nuclear export of viral mRNA such as EBV, and has good therapeutic potential for NKTCL. Selinexor combined with pemaspartase, dexamethasone and sequential radiotherapy may be the golden choice for early NK/T cell lymphoma, improving the local control rate of the disease and improving the overall prognosis of NK/T cell lymphoma. Receives: Drug: Selinexor+pegaspargase+dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRR
The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete mitigation.
Measured: From date of randomization until the date tumor volume has reduced, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Sep 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NKTCLStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Climbing stage, and the following two stages of research
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingzhi Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mingzhi Zhang, Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559553
- Sponsor's protocol ID
- hnslblzlzx202207
- Acronym
- Selinexor
- Status last verified
- Jul 2025
- First submitted
- 15 Aug 2024
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of "Selinexor+Pegaspargase+Dexamethasone" in the Treatment of Stage Ⅰ/Ⅱ NK/ T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06559553
- Acronym / sponsor ID
- Selinexor / hnslblzlzx202207
- Keywords
- NKTCL, Selinexor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mingzhi ZhangUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Aug 2024 (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.
evaluate the efficacy and safety of "Selinexor+pegaspargase+dexamethasone" in early stage NK/ T-cell lymphoma
Detailed description
Patients with early NK/T cell lymphoma were treated with an oral regimen of \"Selinisol + pemaspartase + dexamethasone\"
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Climbing stage, and the following two stages of research
| Arm | Type | Receives |
|---|---|---|
| Selinexor+pegaspargase+dexamethasone | Experimental | Drug: Selinexor+pegaspargase+dexamethasoneNuclear export protein-1 is the main transporter protein for leucine-rich proteins to enter the cytoplasm from the nucleus through the nuclear pore complex, which is overexpressed in malignant tumor cells. Studies have shown that Selinexor inhibits the nuclear export of viral mRNA such as EBV, and has good therapeutic potential for NKTCL. Selinexor combined with pemaspartase, dexamethasone and sequential radiotherapy may be the golden choice for early NK/T cell lymphoma, improving the local control rate of the disease and improving the overall prognosis of NK/T cell lymphoma. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-70 years old, ECOG score 0-2; (including those aged 18 and 70);
- Pre-survival time \> 6 months;
- The pathological tissue was confirmed as NK/T cell lymphoma (the pathological report of the first three months of enrollment could be accepted) (Note: If there is any doubt about the pathological diagnosis, domestic third-party consultation could be organized);
- Clinical stage Ⅰ to Ⅱ (CA stage) with at least one measurable lesion;
- Acceptable hematological indicators, no contraindications to chemotherapy; Neutrophil absolute value ≥1.0×10^9 /L, platelet ≥75×10^9 /L, hemoglobin ≥80g/L (except patients with lymphoma bone marrow infiltration);
Key exclusion criteria (13 listed)
- Refuse to collect blood samples;
- Previous allergy to any of the drugs in the program;
- Pregnant and lactating women;
- Major diseases that the investigator believes can cause interference with the test;
- Combined with other tumors;
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 |
|---|---|---|
| Selinexor+pegaspargase+dexamethasoneNuclear export protein-1 is the main transporter protein for leucine-rich proteins to enter the cytoplasm from the nucleus through the nuclear pore complex, which is overexpressed in malignant tumor cells. Studies have shown that Selinexor inhibits the nuclear export of viral mRNA such as EBV, and has good therapeutic potential for NKTCL. Selinexor combined with pemaspartase, dexamethasone and sequential radiotherapy may be the golden choice for early NK/T cell lymphoma, improving the local control rate of the disease and improving the overall prognosis of NK/T cell lymphoma. | Drug | Selinexor+pegaspargase+dexamethasone |
Primary outcome
CRR
Time frame: From date of randomization until the date tumor volume has reduced, assessed up to 36 months
The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete mitigation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Selinexor+pegaspargase+dexamethasone in people with NKTCL and Selinexor, run by Mingzhi Zhang 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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 14 Jul 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhang Mingzhi Mingzhi Zhang, PhD (86 13838565629, Mingzhi_zhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRR (time frame: From date of randomization until the date tumor volume has reduced, assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2025.