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

ConditionLymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorWon Seog Kim

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: Tislelizumab therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete response rate

The percentage of subjects with complete response(CR)

Time frame
After induction therapy is completed, Every 6 cycles of maintenance, up to 51 months every 6month
2

Overall response rate

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

Secondary outcomes

1

Duration of response

Time frame
Up to 51 months
2

Progression free-survival

The time until defined by date of all-cause mortality from the date of investigational procuct administration

Time frame
Up to 51 months
3

Overall survival

It is a measure of the period of survival without disease progression

Time frame
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
4

Time to response

Time frame
Up to 51 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Won Seog Kim

Lead sponsor

Samsung Medical Center

Sponsor institution

Source ClinicalTrials.gov
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