LymphomaPhase 2NCT06573151
Selinexor, Anti-PD-1 Antibody and P-GemOx Regimen in R/R NKTCL
A Phase 2 study testing Selinexor, anti-PD-1 antibody and P-GemOx in people with Lymphoma, run by Ruijin Hospital.
Trial summary
A multicenter, prospective trial to evaluate the efficacy and safety of Selinexor, anti-PD-1 antibody and P-GemOx in the treatment of relapsed or refractory Natural Killer / T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Selinexor, anti-PD-1 antibody and P-GemOx
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Jul 2027
- Phase
- Phase 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed histological diagnosis of NKTCL nasal type
- The subject had received prior adequate anti-lymphoma therapy containing asparaginase
- Age 14-75 years old
- Expected to live longer than 3 months
- At least one measurable/evaluable site after diagnostic biopsy before treatment start
- ECOG performance status of 0-2
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- Adequate hematological and organ function; i.e. ANC >1000 cells /mmc, platelet counts > 50.000/mmc, Hemoglobin > 9 g/dl AST, ALT <3 x ULN; serum bilirubin < 1.5x ULN (patient with Gilbert disease can be enrolled) Serum creatinine < 2 x ULN or creatinine clearance > 50ml/min
- Tumor tissue (fresh preferred, archival tissue is also acceptable)
- For women of childbearing potential a negative pregnancy test on day 1 of cycle 1 and agree to adopt adequate measure to avoid pregnancy during study treatment and for at least one year from EOT.
- For men agreement to remain abstinent or to use barrier contraception
- Signed Informed consent
Who cannot join
- Confirmed histological diagnosis of aggressive NK cell leukemia
- Evidence of suspect of CNS disease.
- Has an active autoimmune disease that has required systemic treatment in past 2-years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs), including but not limited to myotonia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associate with antiphospholipid syndrome, wegener's granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis. The following exception are allowed: patients with autoimmune related hypothyroidism or type I diabetes mellitus who are on stable treatment. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Treatment with systemic immunosuppressive medications, including prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and anti tumor necrosis factor (anti-TNF) agents within 2 weeks prior to cycle 1 day 1; inhaled corticosteroids are allowed.
- Active infection requiring systemic therapy
- History of (non-infectious) pneumonitis that required steroids; evidence of interstitial lung disease or active, non-infectious pneumonitis
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- Significant cardiovascular disease, myocardial infarction in the previous 3 months, unstable arrhythmias, or unstable angina.
- History of other(s) infiltrating cancer(s) in the previous 3 years that were not treated with curative intent or who are still receiving anticancer therapy (including hormone therapy for breast or prostate cancer).
- HBsAg, HCV or HIV positivity. Positive serology is admitted for HBV and HCV but DNA/RNA test must be negative
- Pregnant or lactating women
- Administration of a live attenuated vaccine within 4 weeks before cyle 1 day 1. Patients must not receive live, attenuate vaccines, including influenza vaccines at any time during study.
- Other uncontrollable medical condition that may interfere the participation of the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy and Safety of Selinexor, Anti-PD-1 Antibody and P-GemOx Regimen in the Treatment of Relapsed or Refractory Natural Killer / T-cell Lymphoma
A multicenter, prospective trial to evaluate the efficacy and safety of Selinexor, anti-PD-1 antibody and P-GemOx in the treatment of relapsed or refractory Natural Killer / T-cell lymphoma.
Read the detailed description
This study aims to evaluate the efficacy and safety of Selinexor, anti-PD-1 antibody plus P-GemOx in relapsed or refractory NKTCL and find the optimal treatment regimen for patients with relapsed refractory NKTCL.
Patients receive 3 cycles of Selinexor, anti-PD-1 antibody plus P-GemOx, and then PET evaluation.
- Conditions
- Lymphoma
- Being tested
- Selinexor, anti-PD-1 antibody and P-GemOx
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selinexor, anti-PD-1 antibody and P-GemOxDrug
Selinexor, 40mg, qw, po; Pegaspargase, 2500U/m2, IM, d1; Gemcitabine, 1000mg/m2, i.v., d1, d8; Oxaliplatin, 130mg/m2, i.v., d1; anti-PD1 antibody, 200mg, d2, i.v. (21d cycle);
| Study group | Role | What they receive |
|---|---|---|
| Chemo | Experimental | Patients receive 3 cycles of Selinexor, anti-PD-1 antibody plus P-GemOx. Receives: Drug: Selinexor, anti-PD-1 antibody and P-GemOx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best CRR
CRR defined according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy.
Measured: through study completion, an average of 1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573151
- Sponsor's protocol ID
- RJ-NKTCL-5
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Selinexor, Anti-PD-1 Antibody and P-GemOx Regimen in the Treatment of Relapsed or Refractory Natural Killer / T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06573151
- Acronym / sponsor ID
- RJ-NKTCL-5
- Conditions
- Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 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.
A multicenter, prospective trial to evaluate the efficacy and safety of Selinexor, anti-PD-1 antibody and P-GemOx in the treatment of relapsed or refractory Natural Killer / T-cell lymphoma.
Detailed description
This study aims to evaluate the efficacy and safety of Selinexor, anti-PD-1 antibody plus P-GemOx in relapsed or refractory NKTCL and find the optimal treatment regimen for patients with relapsed refractory NKTCL.
Patients receive 3 cycles of Selinexor, anti-PD-1 antibody plus P-GemOx, and then PET evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemo | Experimental | Drug: Selinexor, anti-PD-1 antibody and P-GemOxPatients receive 3 cycles of Selinexor, anti-PD-1 antibody plus P-GemOx. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Confirmed histological diagnosis of NKTCL nasal type
- The subject had received prior adequate anti-lymphoma therapy containing asparaginase
- Age 14-75 years old
- Expected to live longer than 3 months
- At least one measurable/evaluable site after diagnostic biopsy before treatment start
Key exclusion criteria (12 listed)
- Confirmed histological diagnosis of aggressive NK cell leukemia
- Evidence of suspect of CNS disease.
- Has an active autoimmune disease that has required systemic treatment in past 2-years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs), including but not limited to myotonia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associate with antiphospholipid syndrome, wegener's granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis. The following exception are allowed: patients with autoimmune related hypothyroidism or type I diabetes mellitus who are on stable treatment. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Treatment with systemic immunosuppressive medications, including prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and anti tumor necrosis factor (anti-TNF) agents within 2 weeks prior to cycle 1 day 1; inhaled corticosteroids are allowed.
- Active infection requiring systemic therapy
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, anti-PD-1 antibody and P-GemOxSelinexor, 40mg, qw, po; Pegaspargase, 2500U/m2, IM, d1; Gemcitabine, 1000mg/m2, i.v., d1, d8; Oxaliplatin, 130mg/m2, i.v., d1; anti-PD1 antibody, 200mg, d2, i.v. (21d cycle); | Drug | Chemo |
Primary outcome
Best CRR
Time frame: through study completion, an average of 1 year]
CRR defined according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy.
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 27 Aug 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selinexor, anti-PD-1 antibody and P-GemOx in people with Lymphoma, run by Ruijin Hospital.
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 11 inclusion and 12 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: opening soon, as of the sponsor's last update on 27 Aug 2024. 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?
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 Weili Zhao, Prof. (008602164370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best CRR (time frame: through study completion, an average of 1 year]). 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 27 Aug 2024.