- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06069830
PET and EBV DNA-directed Therapy for Localized Nasal Extranodal NK/T Cell Lymphoma (ENKTL)
September 29, 2023 updated by: Zhao Weili, Ruijin Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
- Drug: 4 cycles of ESA regimen with sandwiched radiotherapy
- Drug: 2 cycles of ESA regimen sequential radiotherapy and 2 cycles of PD-1 monoclonal antibody combined with pegaspargase
- Drug: 2 cycles of ESA regimen, 2 cycles of PD-1 monoclonal antibody and concurrent radiotherapy, 2 cycles of PD-1 monoclonal antibody combined with pegaspargase
Detailed Description
This study aims to evaluate the significance of mid-term PET and EBV DNA-directed therapy for localized nasal ENKTL.
Patients receive 2 cycles of ESA (Pegaspargase, Etoposide, Dexamethasone) regimen, then according to the mid-term PET and EBV DNA results, patients are divided into three cohorts: 1) cohort A: patients with Deauville score 1-3 and EBV DNA negative receive sequential radiotherapy and 2 cycles of ESA regimen; 2) cohort B: patients with Deauville score 1-3 and EBV DNA positive receive sequential radiotherapy and 2 cycles of PD-1 monoclonal antibody combined with pegaspargase; 3) cohort C: patients with Deauville score 4-5 receive 2 cycles of PD-1 monoclonal antibody and concurrent radiotherapy, then 2 cycles of PD-1 monoclonal antibody combined with pegaspargase.
Study Type
Interventional
Enrollment (Estimated)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Weili Zhao
- Phone Number: +862164370045
- Email: zwl_trial@163.com
Study Contact Backup
- Name: Pengpeng Xu
- Phone Number: +862164370045
- Email: pengpeng_xu@126.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200020
- Ruijin Hospital
-
Contact:
- Weili Zhao
- Phone Number: 610707 +862164370045
- Email: zwl_trial@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion 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 <2 times ULN or creatinine clearance rate> 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.
Exclusion Criteria:
- 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, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome related vascular thrombosis, Wegener's granuloma, Sjogren's syndrome, Guillain Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis. The following cases are allowed to be included: autoimmune hypothyroidism or type I diabetes receiving stable treatment, hormone replacement treatment (such as thyroxine, insulin, or supplement of physiological hormone due to insufficient adrenal or pituitary gland) are not considered as systematic treatment and are allowed to be included.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interim PET and EBV DNA-directed therapy
According to the interim PET and EBV DNA results, patients are divided into three cohorts: 1) cohort A: Deauville score 1-3 and EBV DNA negativity; 2) cohort B: Deauville score 1-3 and EBV DNA positivity; 3) cohort C: Deauville score 4-5.
|
Pegaspargase, 2500U/m2, i.m. d1; etoposide, 200mg, p.o., d2-d4; Dexamethasone, 40mg, p.o. d2-d4;
Pegaspargase, 2500U/m2, IM, d1; PD-1 monoclonal antibody, 200mg, i.v.
d2;
PD-1 monoclonal antibody, 200mg, i.v.
d1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2-year progression-free survival rate
Time Frame: Baseline up to data cut-off (up to approximately 2 years)
|
Progression-free survival was defined as the time from the date of randomization until the date of the first disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
|
Baseline up to data cut-off (up to approximately 2 years)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2-year overall survival rate
Time Frame: Baseline up to data cut-off (up to approximately 2 years)
|
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
|
Baseline up to data cut-off (up to approximately 2 years)
|
2-year PFS and OS rates in the subgroups of interim Deauville score 1-3 with EBV DNA negative, Deauville 1-3 with EBV DNA positive, and Deauville 4-5
Time Frame: Baseline up to data cut-off (up to approximately 2 years)
|
PFS was progression-free survival; OS was overall survival.
|
Baseline up to data cut-off (up to approximately 2 years)
|
Objective response rate
Time Frame: End of treatment (6-8 weeks after last cycle)
|
Percentage of participants with complete response and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
|
End of treatment (6-8 weeks after last cycle)
|
Complete response rate
Time Frame: End of treatment (6-8 weeks after last cycle)
|
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
|
End of treatment (6-8 weeks after last cycle)
|
Treatment-Related Adverse Events rate as assessed by CTCAE version 5.0
Time Frame: From enrollment to study completion, a maximum of 3 years
|
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Preexisting conditions which worsen during a study are also considered as adverse events.
|
From enrollment to study completion, a maximum of 3 years
|
Changes of plasma EBV DNA load
Time Frame: From enrollment to study completion, a maximum of 3 years
|
Plasma EBV DNA load monitoring
|
From enrollment to study completion, a maximum of 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
September 29, 2023
First Submitted That Met QC Criteria
September 29, 2023
First Posted (Actual)
October 6, 2023
Study Record Updates
Last Update Posted (Actual)
October 6, 2023
Last Update Submitted That Met QC Criteria
September 29, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Lymphoma, Extranodal NK-T-Cell
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Antibodies
- Immunoglobulins
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
- Asparaginase
- Pegaspargase
Other Study ID Numbers
- PENK
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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