Concurrent Tislelizumab and Radiotherapy in Newly Diagnosed Extranodal NK/T-cell Lymphoma, Nasal Type

Recruiting now · Phase 2

Conditions studied: Lymphoma

In brief

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. As a rationale for using PD-1 inhibitors in patients with NK/T-cell lymphoma, their efficacy has been proved several times mostly in patients with relapsed NK/T-cell lymphoma. Patients with low-stage NK/T-cell lymphoma usually receive high-concentration cytotoxic chemotherapy combined with radiotherapy, with treatment response rates of approximately 60 to 80%, but 80-90% of them experience hematological and non-hematologic toxicities during treatment. Therefore, this study intends to determine the efficacy and safety of PD-1 inhibitor(Tislelizumab) combined with radiotherapy as a first-line therapy compared with pre-existing cytotoxic chemotherapy combined with radiotherapy in patients with NK/T-cell lymphoma with low stage and International Prognostic Index.

Key facts

Study ID: NCT05477264
Run by: Won Seog Kim
People needed: 38
Starts: 2023-03-02
Expected to finish: 2026-12-31
Last updated by the study team: 2024-04-03

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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
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 subjects 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 subjects, 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

You may not qualify 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 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 acceptable
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 subjects's participation in the clinical trial. Other severe acute or chronic medical conditions include colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis, or psychiatric conditions, including recent(in the last 1 year) or active suicidal thoughts or behaviors: or laboratory abnormalities the, in the investigator's opinion, may increase the risk associated with participation in the clinical trial or study treatment, or that may interfere with the interpretation of clinical trial results.
Active infection requiring ststemic therapy
Active autoimmune disease that may be exacerbated upon administration of immunostimulants. However, subjects with type I diabetes mellitus, vitiligo, psoriasis, or hypothyroidism or hyperthyroidism not requiring immunosuppressive treatment are eligible
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.

Where it is running

81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.