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New treatment option for NK-T-Cell Lymphoma, Extranodal
Official title PET and EBV DNA-directed Therapy for Localized Nasal Extranodal NK/T Cell Lymphoma
ClinicalTrials.gov ID: NCT06069830
What this study is testing
What is 4 cycles of ESA regimen with sandwiched radiotherapy?
4 cycles of ESA regimen with sandwiched radiotherapy is an investigational medicine, being studied as a potential treatment for nk-t-cell lymphoma, extranodal.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A prospective, open-abel, phase 2 clinical study to investigate whether interim Positron Emission Tomography (PET) and Epstein-Barr virus (EBV) DNA-directed therapy can improve the prognosis of localized nasal extranodal NK/T cell lymphoma (ENKTL) patients.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically newly diagnosed extranodal NK/T cell lymphoma, nasal type (according to the WHO classification 2016);
- No previous anti-lymphoma treatment;
- Age ≥ 18 years old;
- Ann Arbor stage I/II;
- ECOG 0-2 score;
You likely can't join if
- Diagnosed invasive NK cell leukemia and extranasal ENKTL;
- Ann Arbor stage III/IV;
- Pregnant or lactation;
- Autoimmune diseases that require systemic treatment in the past 2 years (namely, antirheumatic drugs, hormones or immunosuppressants), including but...
- Other invasive cancers that have not received curative treatment or are still receiving anti-cancer treatment (including hormone therapy for breast...
- Pneumonia requiring steroid medication treatment (non-infectious); Or had clinical evidence of interstitial lung disease or active and non-infectious...
See the full eligibility criteria
- Pathologically newly diagnosed extranodal NK/T cell lymphoma, nasal type (according to the WHO classification 2016);
- No previous anti-lymphoma treatment;
- Age ≥ 18 years old;
- Ann Arbor stage I/II;
- ECOG 0-2 score;
- Patients with a life expectancy of at least 3 months;
- At least one measurable / evaluable lesion from diagnostic biopsy to the beginning of treatment;
- Sufficient bone marrow and liver and kidney function, namely:
- Absolute neutrophil count (ANC)\> 1000 / μL, platelet count\> 50, 000 / μl, hemoglobin\> 9g/ dl;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<3 times the upper limit of normal (ULN); Serum total bilirubin \<1. 5 times ULN (patients with Gilbert syndrome can be included);
- Serum creatinine \ 50 ml/min.
- Able to comply with the research procedures and cooperate in the implementation of the entire research process;
- Written informed consent;
- Women with fertility agree to take appropriate measures to avoid pregnancy during the treatment period until at least one year after the end of treatment; Men agree to maintain abstinence or use barrier contraception.
- Diagnosed invasive NK cell leukemia and extranasal ENKTL;
- Ann Arbor stage III/IV;
- Pregnant or lactation;
- Autoimmune diseases that require systemic treatment in the past 2 years (namely, antirheumatic drugs, hormones or immunosuppressants), including but not limited to myasthenia gravis, myositis, autoimmune hepatitis...
- Other invasive cancers that have not received curative treatment or are still receiving anti-cancer treatment (including hormone therapy for breast cancer or prostate cancer) in the past 3 years;
- Pneumonia requiring steroid medication treatment (non-infectious); Or had clinical evidence of interstitial lung disease or active and non-infectious pneumonia;
- Active infections that require systemic treatment;
- Severe cardiovascular disease, or myocardial infarction, unstable arrhythmia, or unstable angina pectoris occurring 3 months ago;
- Previous treatment with anti PD-1, anti PD-L1, or anti PD-L2 drugs;
- HBsAg, HCV, or HIV positivity; HBV and HCV serological positivity is allowed, but DNA/RNA must be negative;
- Live attenuated vaccine vaccination within 4 weeks before the treatment; patients are prohibited from receiving live attenuated vaccines during the study period, including influenza vaccines;
- Central nervous system diseases;
- Previous allogeneic tissue/solid organ transplantation;
- Active tuberculosis;
- Other concurrent uncontrollable medical conditions that may interfere the participation of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.