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New treatment option for NK/T Cell Lymphoma
Official title A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma
ClinicalTrials.gov ID: NCT07000617
What this study is testing
What is DAPT regimen plus radiotherapy?
DAPT regimen plus radiotherapy is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for nk/t cell lymphoma.
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
- The goal of this clinical trial is to learn if the regimen of dexamethasone, azacitidine, pegaspargase and tislelizumab (DAPT regimen) combined with radiotherapy works to treat stage I or II NK/T cell lymphoma in adults. It will also learn about the safety of the DAPT regimen.
- Phase 2: a mid-size study of how well it works
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 confirmed diagnosis of extranodal NK/T-cell lymphoma
- Age ≥18 years
- Ann Arbor stage I or II
- Presence of at least 1 measurable lesion according to the 2014 Lugano revised criteria for response assessment
- ECOG-PS 0\~2
You likely can't join if
- Unconfirmed pathological diagnosis of NK/T-cell lymphoma
- Pregnant or lactating women, or patients of childbearing age unwilling to take contraceptive measures during the study period.
- Patients with clinically significant prolonged QTc interval (\>470ms in males, \>480ms in females), ventricular tachycardia, atrial fibrillation...
- Patients with large amount of pericardial effusions shown by echocardiogram.
- Patients who received supportive care for anemia, neutropenia or thrombocytopenia within 7 days prior to start of study treatment.
- Patients with severe active bleeding.
See the full eligibility criteria
- Pathologically confirmed diagnosis of extranodal NK/T-cell lymphoma
- Age ≥18 years
- Ann Arbor stage I or II
- Presence of at least 1 measurable lesion according to the 2014 Lugano revised criteria for response assessment
- ECOG-PS 0\~2
- Peripheral blood absolute neutrophil count ≥1.5×10E9/L, platelet count ≥75×10E9/L and hemoglobin ≥90g/L
- Expected survival of at least 3 months
- Capable of understanding the content of this study, agreeing to participate in this study and signing the informed consent.
- Unconfirmed pathological diagnosis of NK/T-cell lymphoma
- Pregnant or lactating women, or patients of childbearing age unwilling to take contraceptive measures during the study period.
- Patients with clinically significant prolonged QTc interval (\>470ms in males, \>480ms in females), ventricular tachycardia, atrial fibrillation, second or third degree atrioventricular block, acute myocardial...
- Patients with large amount of pericardial effusions shown by echocardiogram.
- Patients who received supportive care for anemia, neutropenia or thrombocytopenia within 7 days prior to start of study treatment.
- Patients with severe active bleeding.
- Patients with pulmonary embolism, intracranial hemorrhage or acute cerebral infarction.
- Patients with active infectious disease.
- Patients who are mentally disabled or unable to understand or sign the informed consent form.
- Patients with other conditions judged as ineligible for this study by the investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 Beijing, 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.