Actively Recruiting

Phase 2
Age: 19Years +
All Genders
NCT05477264

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

Led by Won Seog Kim · Updated on 2024-04-03

38

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically diagnosed extranodal NK/T-cell lymphoma
  • No history of prior treatment for this lymphoma
  • Stage IE or IIE involving nasal cavity, nasopharynx, or oral cavity only
  • International Prognostic Index (PINK, PINK-E) score of 0 to 1
  • Age 19 years or older
  • ECOG Performance Status of 0 to 2
  • At least one measurable lesion 1.5 cm or larger on CT or PET/CT scan
  • Adequate bone marrow function: absolute neutrophil count > 1,500/mm3, hemoglobin > 9.0 g/dL, platelet count > 75,000/mm3 (unless cytopenia is from bone marrow involvement)
  • Adequate organ function: total bilirubin and AST/ALT less than 3 times upper limit of normal, serum creatinine ≤ 2.0 mg/dL
  • Voluntary written informed consent for chemotherapy and radiotherapy
  • For women of childbearing potential, negative pregnancy test at screening
  • Use of highly effective contraception during study and for 6 months after last dose if at risk of pregnancy
  • Availability of stored tumor tissue sample for targeted sequencing
Not Eligible

You will not qualify if you...

  • Previous treatment with chemotherapy, radiotherapy, or targeted therapy for extranodal NK/T-cell lymphoma
  • Stage III or IV disease, or stage IE-IIE with extranodal involvement beyond nasal, nasopharynx, or oral cavity areas
  • International Prognostic Index (PINK, PINK-E) score of 2 or higher
  • Other active malignancy or malignancy within past 3 years except treated basal or squamous cell carcinoma or cervical carcinoma in situ
  • Major surgery within 21 days before study or unresolved serious side effects from surgery
  • Use of immunosuppressants except low-dose steroids, local steroid treatments, or premedication steroids for hypersensitivity
  • Significant cardiovascular disease including recent stroke, heart attack, unstable angina, heart failure (NYHA class II or higher), or serious arrhythmias
  • Other severe or uncontrolled medical conditions such as uncontrolled diabetes, chronic pancreatitis, active chronic hepatitis, colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis, psychiatric conditions including recent or active suicidal thoughts
  • Active infection requiring systemic therapy
  • Active autoimmune disease that could worsen with immunostimulants (except controlled type I diabetes, vitiligo, psoriasis, or thyroid disorders not needing immunosuppressants)
  • Unable to understand or comply with study requirements or history of noncompliance
  • Pregnant or breastfeeding women
  • Live vaccines within 2 weeks before first dose of tislelizumab or during study (except influenza and COVID vaccines), inactivated vaccines allowed
  • Hepatitis B virus-related liver disease including chronic hepatitis with cirrhosis, HBV reactivation, or active HBV/HCV infection at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea

Seoul, South Korea, 06351

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here