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

NCT05477264 | Recruiting Phase 2 DMC

• 1 other identifier: 2022-03-082
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lymphoma

Outcome Measures

Primary Outcomes (2)

• Complete response rate

  The percentage of subjects with complete response(CR)

  After induction therapy is completed, Every 6 cycles of maintenance, up to 51 months every 6month

• Overall response rate

  After induction therapy is completed, Every 6 cycles of maintenance, up to 51 months every 6month

Secondary Outcomes (5)

• Duration of response

  Up to 51 months

• Progression free-survival

  Up to 51 months

• Overall survival

  the time between the date of treatment start and the date of death due to any cause of disease progression assessed up to 51 months

• Time to response

  Up to 51 months

• Adverse events

  From the day 1 of the clinical trial to 28 days after last drug administration

Study Arms (1)

Tislelizumab therapy

EXPERIMENTAL

Induction therapy: Tislelizumab combined with radiation Maintenance therapy(after termination of combination therapy)

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

Induction therapy: Tislelizumab combined with radiation * Tislelizumab: 200mg, IV at 3-week intervals combined with radiotherapy. * Radiotherapy: 400Gy/20 fractions Maintenance therapy(after termination of combination therapy) * Tislelizumab: 200mg IV at 3-week intervals for up to 2 years until disease progression or intolerance.

Tislelizumab therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

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

Sponsors & Collaborators

• Won Seog Kim: lead

Study Sites (1)

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

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: March 2, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

KR (1)