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LymphomaPhase 2NCT05477264

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

A Phase 2 study testing Tislelizumab in people with Lymphoma, run by Won Seog Kim at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Lymphoma
What is being tested?
Tislelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteSouth Korea
Study dates
2 Mar 2023to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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
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  • 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

Who cannot join

  • 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:
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  • 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.
  • 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 subjects 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site, 1 recruiting

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

    Seoul, 06351

    Kim Wonseog, phD, 82-10-9933-5823, wonseog.kim@samsung.com

    shin hyunjung, 82-2-3410-6763, hjds.shin@samsung.com

    Recruiting

Other trials in South Korea

About this study

Official title: Phase II Study of Concurrent Tislelizumab and Radiotherapy for Treatment-naïve, Newly Diagnosed Low-risk Extranodal NK/T-cell Lymphoma, Nasal Type

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.

Read more

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.

Read the detailed description

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.

However, a tumor-immune microenvironment(TIME) analysis at our institution confirmed that patients with relapsed or refractory NK/T-cell lymphoma had a peritumoral microenvironment with suppressed activity of T cells and macrophages (immune suppression, IS), in which case the efficacy of PD-1 inhibitor decreased compared to a more immune-active microenvironment (immune evasion or immune tolerance, IE or IT). On the other hand, most patients who were newly diagnosed with NK/T-cell lymphoma had a peritumoral microenvironment with active T cells and macrophages(IE or IT).

Patients with low-stage(Stage IE or IIE) 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 grade 3 or 4 hematological and non-hematologic toxicities during treatment.

Therefore, based on the tumor microenvironment of NK/T-cell lymphoma, 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
Being tested
Tislelizumab
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

    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.
Study groups in NCT05477264
Study groupRoleWhat they receive
Tislelizumab therapyExperimentalInduction therapy: Tislelizumab combined with radiation Maintenance therapy(after termination of combination therapy)
Receives: Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rate

    The percentage of subjects with complete response(CR)

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

  2. Overall response rate

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

Secondary outcomes (5)

  1. Duration of response

    Measured: 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

    Measured: Up to 51 months

  3. Overall survival

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

    Measured: 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

    Measured: Up to 51 months

  5. Adverse events

    Investigation of adverse events occurred in subject

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2022
  2. Study start2 Mar 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05477264
Sponsor's protocol ID
2022-03-082
Status last verified
Apr 2024
First submitted
26 Jul 2022
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab in people with Lymphoma, run by Won Seog Kim at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (time frame: After induction therapy is completed, Every 6 cycles of maintenance, up to 51 months every 6month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05477264.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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