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Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypePhase 2NCT03936452

Combined Treatment of Sintilimab, Peg-aspargase Plus Anlotinib in NK/T Cell Lymphoma

A Phase 2 study testing Sintilimab in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type and Early Stage, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to investigate the treatment of previously untreated stage I-II Extranodal NK/T Cell Lymphoma with sintilimab, peg-aspargase and anlotinib, "sandwich" with radiotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Sintilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteChina
Study dates
28 Apr 2019to 30 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed NK/T cell lymphoma;
  • Male or female: ≥18 and ≤70 years old;
  • Eastern Cooperative Oncology Group (ECOG) status 0-3;
  • Estimated survival time > 3 months;
  • No previous anti-tumor therapy including radiotherapy, chemotherapy, targeted therapy or stem cell transplantation;
  • At least one evaluable or measurable lesion complying with Lugano 2014 Standard (evaluable lesion: the examination show increased uptake of lymph nodes or extranodal areas (higher than that of the liver) by 18F-Fluorodeoxyglucose/ Positron Emission Tomography (18FDG/PET) and the PET and/or Computed Tomography (CT) features coincide with lymphoma characteristics; measurable lesion: sarcoidal lesions were longer than 15 mm or extranodal lesions were longer than 10 mm, and accompanied by increased 18FDG uptake). Increased liver diffuse 18FDG uptake without measurable lesions should be excluded.
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  • The main organs function well, namely, the following requirements were met one week before admission: Blood routine WBC ≥ 3.5×109/L, Hb ≥ 100g/L and PLT ≥ 90×109/L; Heart and liver function were normal (total bilirubin ≤1.5×ULN, ALT and AST ≤ 2.5×ULN), renal function was normal (serum creatinine ≤1.5×upper limitation of normal (ULN)), and without abnormal coagulation function.
  • Fertile patients must undergo pregnancy tests (serum or urine) within 14 days prior to study enrollment and the results are negative, and they are willing to use effective contraception during the trial;
  • The imaging evaluation was Ann Arbor stage I/II.
  • Voluntary participation and signed the informed consent, good compliance, with follow-up.

Who cannot join

  • Patients allergic of any of drug in this regimen;
  • Pregnant or lactating women
  • Participated in other clinical trials within the 4 weeks prior to enrollment;
  • Previous treatments with small molecule tyrosine kinase inhibitors, including familinib,sorafenib, sunitinib, regofinib, anlotinib, furquintinib, etc.
  • Imaging showed tumors have involved important blood vessels (e.g. enveloping internal carotid artery/vein), or by investigators determine highly likely during the follow-up study and cause fatal hemorrhage
  • History of severe hemorrhage, or any bleeding events with a severe grade of 3 or more in CTCAE 4.0 within 4 weeks prior to enrollment
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  • Blood pressure unable to be controlled ideally with single antihypertensive drug therapy (Systolic blood pressure > 140 mmHg, Diastolic Blood Pressure > 90 mmHg); Clinically significant cardiovascular disease (e.g. activity) including history of CVA (within 6 months), myocardial infarction (within 6 months), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure; serious cardiac arrhythmia beyond drug control or potentially affecting experimental therapy.
  • Active ulcer, intestinal perforation or intestinal obstruction;
  • History of gastrointestinal perforation within 28 days prior to enrollment;
  • Various factors affecting the oral administration and absorption of drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
  • Abnormal coagulation or bleeding tendency (It must be satisfied that INR is under normal range without anticoagulant within 14 days prior to signing informed consent); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; on the premise that the international standardized ratio of prothrombin time (INR) is less than 1.5, small doses of warfarin (1 mg po, qd) or aspirin (no more than 100 mg qd) are allowed for preventive purposes.
  • Arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (venous thrombosis caused by intravenous catheterization due to precancerous chemotherapy is excluded if it has been cured judged by the researchers) and pulmonary embolism.
  • Renal insufficiency: routine urine tests indicate that urine protein is more than + +, or 24 hours urine protein is more than 1.0 g.
  • Suffered major surgery within 28 days prior to enrollment;
  • Received strong inhibitors of CYP3A4 within a week or strong inducers of CYP3A4 within 2 weeks prior to enrollment.
  • Long-term non-healing wound or incomplete-healing fracture.
  • Symptomatic brain metastases (confirmed or suspected);
  • Severe or uncontrolled infections
  • History of psychotropic drug abuse and unable to get rid of or with mental disorders;
  • History of immunodeficiency, including HIV positive testing, or other acquired, congenital immunodeficiency disorders, or organ transplantation history;
  • Previous and present objective evidences including history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severe impairment of pulmonary function.
  • History of other malignancy within the last 5 years prior to enrollment, except for cured basal cell carcinoma of skin, cervix in situ carcinoma and superficial bladder cancer;Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: An Open, Single-center, Phase II Study of Sintilimab, Peg-aspargase Plus Anlotinib "Sandwich"With Radiotherapy in Previously Untreated Stage I-II Extranodal NK/T Cell Lymphoma

This study aims to investigate the treatment of previously untreated stage I-II Extranodal NK/T Cell Lymphoma with sintilimab, peg-aspargase and anlotinib, "sandwich" with radiotherapy.

The primary endpoint is the complete response rate (CRR) at the end of the treatment, and the second endpoints are CRR after two cycles of the combined regimen (CRR2), overall response rate (ORR) at the end of the treatment, survival time (OS and PFS) and toxicities.

Being tested
Sintilimab

What participants receive

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

  • SintilimabDrug

    Also called Peg-aspargase, Anlotinib

    Sintilimab 200mg ivdrip D1 Anlotinib 12mg po D1-14 Peg-aspargase 2500U/m2 im D1 combined with radiotherapy

Study groups in NCT03936452
Study groupRoleWhat they receive
Treatment armExperimentalSintilimab 200mg ivdrip D1 Peg-aspargase 2500U/m2 im D1 Anlotinib 12 mg po D1-14 repeat every three weeks When patients obtained an CR or PR after the second dose of the combined regimen, they woud undergo radiotherapy after the third dose of the combined regimen. Subsequently, another three cycles of the combined regimen would be administered to these patients.
Receives: Drug: Sintilimab

What is being measured

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

  1. Complete response rate at the end of the treatment

    Complete response rate at the end of the treatment

    Measured: 12 weeks after the last dose of the regimen

Secondary outcomes (5)

  1. Adverse events

    All the adverse events of the patients related will be assessed and graded by NCI CTCAE v4.0

    Measured: Up to one year after the start of the study

  2. Progression Free Survival (PFS)

    PFS was defined as time from study registration to first disease progression or death whichever occurred first, otherwise subject data were censored at time last known disease free.

    Measured: Up to three years after the start of the study

  3. Overall Survival (OS)

    OS was defined as time from study registration to death, and otherwise censored at time last known alive.

    Measured: Up to three years after the start of the study

  4. Complete response rate after two cycles of the combined regimen

    Complete response rate after two cycles of the combined regimen

    Measured: 4 weeks after the second dose of the combined regimen

  5. Overall response rate at the end of the treatment

    Overall response rate at the end of the treatment

    Measured: 12 weeks after the last dose of the combined regimen

Timeline

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

  1. First posted3 May 2019
  2. Study start28 Apr 2019
  3. Primary completion30 Dec 2021
  4. Study completion30 Dec 2021

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
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03936452
Sponsor's protocol ID
B2019-048-X01
Status last verified
Jun 2022
First submitted
1 May 2019
Last updated
9 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type and Early Stage, run by Sun Yat-sen University at 1 site in China.

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 10 inclusion and 22 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: finished, as of the sponsor's last update on 9 Jun 2022. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate at the end of the treatment (time frame: 12 weeks after the last dose of the regimen). 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 NCT03936452.

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 9 Jun 2022.

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