Selinexor, selective inhibitor of nuclear export: Unselective bullet for blood cancers.
Katerina Benkova, Jana Mihalyova, Roman Hajek...
https://pubmed.ncbi.nlm.nih.gov/32972802Actively Recruiting
Phase 2
Age: 14Years +
All Genders
ID05833893
Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
Led by Chinese PLA General Hospital · Updated on 2023-04-27
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying patients with newly diagnosed, pathologically confirmed advanced NK/T-cell lymphoma at stage III or IV. This study evaluates the combination of the XPO1 inhibitor Selinexor with the COPL chemotherapy regimen over multiple cycles. The purpose is to assess the response rate and safety of this treatment approach in this patient group. The treatment involves the XCOPL regimen consisting of Selinexor taken orally at 60 mg on days 1, 8, and 15 of a 3-week cycle, combined with other chemotherapy agents. Patients receive 6 to 8 cycles of this regimen. After 3 cycles, safety and PET-CT scans assess treatment response. Those achieving partial remission or better continue the original regimen. Patients without sufficient response undergo re-biopsy and may be excluded. After 6 cycles, those still in partial remission may switch to a second-line regimen including GDP combined with Selinexor. Treatment may continue up to 8 cycles, followed by hematopoietic stem cell transplantation and a follow-up period. During the study, participants undergo regular assessments including ultrasound or CT scans, peripheral blood tests for ctDNA and EBV copy number every 3 months in the first year, and PET-CT scans every 6 months. The main outcomes measured are the 1-year response rate and incidence of treatment-emergent adverse events. Secondary outcomes include progression-free survival, overall survival, and blood markers. Follow-up continues after treatment completion to monitor long-term effects and disease status.
CONDITIONS
Brief Title
Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
Who Can Participate
Age: 14Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 14 years or older, any gender
- Newly diagnosed NK/T-cell lymphoma confirmed by pathology according to WHO 2016 criteria
- At least one measurable lesion (intranodal >1.5 cm short axis, extranodal >1.0 cm short axis)
- ECOG performance status between 0 and 2
- Clinical stage III or IV lymphoma
- Normal major organ function, including WBC ≥ 3.5 x10⁹/L, platelets ≥ 75 x10⁹/L, hemoglobin ≥ 80 g/L
- Liver and kidney function within defined limits (AST and ALT ≤ 3.0 ULN, total bilirubin ≤ 2.0 mg/dL, creatinine clearance ≥ 60 mL/min)
- Expected survival longer than 6 months
- Agree to use effective contraception
- Able to understand and voluntarily sign informed consent
You will not qualify if you...
- Prior allogeneic hematopoietic cell transplantation
- Active autoimmune disease
- Primary central nervous system lymphoma
- Active infections requiring treatment (re-enrollment possible after infection control)
- Known HIV infection
- Known allergy to study drugs or components
- Presence of other active cancers needing treatment that would interfere with this study
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Treatment
Duration - Up to 24 weeks (6 to 8 cycles of 3 weeks each)
Participants receive the COPL chemotherapy regimen combined with the XPO1 inhibitor Selinexor in cycles lasting 3 weeks each. Treatment includes 6 to 8 cycles with assessments to evaluate response and safety. Participants who achieve partial remission or better after 3 to 4 cycles continue the regimen; those who do not achieve this may undergo re-biopsy and be excluded. After 6 cycles, participants with partial remission may switch to a second-line regimen. Chemotherapy may be followed by stem cell transplantation.
Cycles repeated every 3 weeks for 6 to 8 cycles with assessments after 3 to 4 cycles and after 6 cycles
Follow-up
Duration - Up to 1 year
Participants are monitored after treatment completion with regular evaluations including ultrasound or CT scans, peripheral blood tests for ctDNA and EBV copy number every three months during the first year, and PET-CT every six months.
Quarterly visits for ultrasound or CT and blood tests, and biannual PET-CT visits
Trial Site Locations
Total: 1 location
1
ChinaPLAGH
Beijing, Haidian, China, 100853
Actively Recruiting
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Research Team
Y
Yu Zhao, Graduate
S
Sai Huang, Graduate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
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Eric Tse, Yok-Lam Kwong
https://pubmed.ncbi.nlm.nih.gov/27347812Beyond first-line non-anthracycline-based chemotherapy for extranodal NK/T-cell lymphoma: clinical outcome and current perspectives on salvage therapy for patients after first relapse and progression of disease.
S H Lim, J Y Hong, S T Lim...
https://pubmed.ncbi.nlm.nih.gov/28911074