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New treatment option for Lymphoma
Official title Concurrent Tislelizumab and Radiotherapy in Newly Diagnosed Extranodal NK/T-cell Lymphoma, Nasal Type
ClinicalTrials.gov ID: NCT05477264
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for 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
- This clinical trial intends to analyze the efficacy of PD-1 inhibitor combined with radiotherapy for newly diagnosed NK/T-cell lymphoma. The investigational product in this clinical trial is tislelizumab, a PD-1 inhibitor.
- 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 19 and older
You may be able to join if
- Histologicallly diagnosed extranodal NK/T-cell lymphoma
- No history of prior treatment
- Stage IE/IIE(cases involving the nasal cavity, nasopharynx, and oral cavity only)
- International prognostic index(PINK, PINK-E risk score): 0-1
- 19 years and older
You likely can't join if
- History of prior treatment(chemotherapy, radiotherapy, or targeted therapy) to treat extranodal NK/T-cell lymphoma
- Stage III/IV at diagnosis or stage IE-IIE with extranodal(cutaneous, soft tissue, gastrointestinal, brain, spinal cord, bone marrow, etc.)
- International prognostic index(PINK, PINK-E): ≥ 2
- Has a concomitant malignancy or had a malignancy(except for appropriately treated basal or squamous cell carcinoma or cervical carcinoma in situ) in...
- Underwent a major surgery within 21 days prior to initiating the study treatment, or has not recovered from serious side effects of surgery
- Concomitant use of immunosuppressants, except for the following:
See the full eligibility criteria
Who can join
- Histologicallly diagnosed extranodal NK/T-cell lymphoma
- No history of prior treatment
- Stage IE/IIE(cases involving the nasal cavity, nasopharynx, and oral cavity only)
- International prognostic index(PINK, PINK-E risk score): 0-1
- 19 years and older
- ECOG PS: 0-2
- AT least one measurable and assessable lesion at least 1.5cm in size on CT or PET/CT scan
- Adequate bone marrow function, as defined by the following laboratory values(If cytopenia is associated with bone marrow involvement, the subject is excluded):
- Absolute neutrophil \> 1,500/mm3
- Hemoglobin \> 9.0g/dL
- Platelet \> 75,000/mm3
- Adequate organ function, as defined by the following laboratory values
- Total bilirubin, AST/ALT \< 3xULN
- Serum creatinine ≤ 2.0mg/dL
- Voluntary written informed consent to undergo chemotherapy and radiotherapy
- Female people are required to meet the following criteria:
- Pregnancy test: For women of childbearing potential, a negative serum or urine pregnancy test at screening
- Contraception: For both male and female people, use of highly effective contraception throughout the study period and, if at risk of pregnancy, for at least 6 months after the last dose of the study treatment
- Having tumor tissue sample in storage available for targeted sequencing
What rules you out
- History of prior treatment(chemotherapy, radiotherapy, or targeted therapy) to treat extranodal NK/T-cell lymphoma
- Stage III/IV at diagnosis or stage IE-IIE with extranodal(cutaneous, soft tissue, gastrointestinal, brain, spinal cord, bone marrow, etc.)
- International prognostic index(PINK, PINK-E): ≥ 2
- Has a concomitant malignancy or had a malignancy(except for appropriately treated basal or squamous cell carcinoma or cervical carcinoma in situ) in the last 3 years prior to initiation of the study treatment
- Underwent a major surgery within 21 days prior to initiating the study treatment, or has not recovered from serious side effects of surgery
- Concomitant use of immunosuppressants, except for the following:
- Intranasal, inhaled, or topical steroid, or local steroid injection(such as intra-articular injection)
- Physiological dose ≤ 10mg/day of prednisone or equivalent doses of systemic corticosteroid
- Premedication with steroids to prevent hypersensitivity reaction(such as premedication prior to a CT scan). At the discretion of the investigator, the use of prednisolone at ≥ 10mg for adrenal insufficiency may be...
- Clinically significant, or active, cardiovascular disease
- Cerebrovascular accient/stroke: within 6 months prior to study entry
- Myocardial infarction: within 6 months prior to study entry
- Unstable angina, congestive heart failure(New York Heart Association class ≥II), or serious cardiac arrhythmias requiring medication, including any of the following
- Left ventricular ejection fraction(LVEF) \< 50% as measured by echocardiography
- QTc\>480msec(using the QTcF formula) on ECG at screening
- unstable angina
- ventricular arrhythmias except for benign premature ventricular contraction
- medically uncontrolled supraventricular and nodal arrhythmias
- conduction abnormality requiring a pacemaker
- valve disease with documented cardiac dysfunction
- Other concomitant severe and/or uncontrolled medical conditions(e.g., uncontrolled diabetes mellitus, chronic pancreatitis, active chronic hepatitis, etc.) that the investigator considers would preclude the people's...
- Active infection requiring ststemic therapy
- Active autoimmune disease that may be exacerbated upon administration of immunostimulants. However, people with type I diabetes mellitus, vitiligo, psoriasis, or hypothyroidism or hyperthyroidism not requiring...
- Incapable of understanding or complying with clinical trial instructions and requirements, or have a history of noncompliance with medical therapy
- Pregnant or nursing(breastfeeding) women. Pregnancy is defined as the condition of a woman form pregnancy as confirmed by positive serum hCG laboratory test(\>5mIU/mL) to termination of pregnancy.
- Live vaccination is prohibited, except for influenza and COVID vaccines are allowed, within 2 weeks prior to the first dose of tislelizumab and during clinical trial participation, and inactivated vaccines are allowed.
- Hepatitis B virus(HBV) related liver disease, such as the following:
- Chronic hepatitis with cirrhosis
- HBV reactivation(However, hepatitis B surface antigen positive people who are asymptomatic and do not require treatment can be enrolled at the discretion of the investigator)
- Hepatitis B virus(HBV) infection at screening(HBV surface antigen-positive and HBV DNA positive)
- Hepatitis C virus(HCV) infection at screening(HCV RNA positive if positive for anti-HCV antibody at screening)
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
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, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. 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.