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Extranodal NK/T-cell Lymphoma, Nasal TypePhase 2SPENTNCT04676789

Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy in Early-Stage ENKTL

A Phase 2 study testing Pegaspargase, Anti-PD-1 monoclonal antibody and Definitive intensity-modulated radiotherapy (IMRT) in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Aim of the trial is to evaluate the safety and efficacy of sintilimab and pegaspargase in combination with pegaspargase for the initial treatment of previously untreated patients with limited stage NK/T cell lymphoma.All eligible patients will be treated with sintilimab combined with pegaspargase administered every 3… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Pegaspargase, Anti-PD-1 monoclonal antibody and Definitive intensity-modulated radiotherapy (IMRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Sep 2021to 31 Dec 2024
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • newly diagnosed ENKTL
  • age:18-80years
  • Ann Arbor stage IE,or stage IIE
  • at lease one measurable lesion
  • receive no chemotherapy or radiotherapy before
  • Eastern CooperativeOncology Group performance status of 0 to 2.
  • Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Who cannot join

  • mismatch the inclusion criteria
  • non-nasal type disease
  • systematic central nervous system involvement
  • previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

Trial locations and contacts

1 site in 1 country.

Hua Wang, MD. contact

0086-20-87342462

wanghua@sysucc.org.cn

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Please Select, 510060

Other trials in China

About this study

Official title: Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy As First-Line Treatment in Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)

Aim of the trial is to evaluate the safety and efficacy of sintilimab and pegaspargase in combination with pegaspargase for the initial treatment of previously untreated patients with limited stage NK/T cell lymphoma.All eligible patients will be treated with sintilimab combined with pegaspargase administered every 3 weeks for 4 cycles followed by standard radiotherapy with or without concurrent sintilimab and pegaspargase administered every 3 weeks. After radiotherapy, patients with complete remission with positive plasma EBV-DNA or partial response will continue with sintilimab maintenance up to 2 years.

Read the detailed description

This is a multicentre, open-label, single-arm, phase II clinical study to evaluate the safety and efficacy of sintilimab and pegaspargase in combination with pegaspargase for the initial treatment of previously untreated patients with limited stage NK/T cell lymphoma.All eligible patients will be firstly treated with sintilimab combined with pegaspargase administered every 3 weeks for 4 cycles. If the patient achieves complete remission（CR）, standard radiotherapy will be performed, otherwise, they will receive concurrent chemoradiotherapy（CCRT）(radiation 50 Gy and two cycles of sintilimab and pegaspargase every 3 weeks). After radiotherapy or CCRT, patients achieving CR with positive plasma EBV-DNA or partial response will continue with sintilimab maintenance up to 2 years.

Being tested
Pegaspargase, Anti-PD-1 monoclonal antibody, Definitive intensity-modulated radiotherapy (IMRT)
Keywords
sintilimab, Pegaspargase, Definitive intensity-modulated radiotherapy (IMRT)
Medical subject headings
Lymphoma, Extranodal NK-T-Cell

What participants receive

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

  • PegaspargaseDrug

    Also called P-ASP

    Pegaspargase 2500IU/m2 administered by intramuscular injection on Day 1

  • Anti-PD-1 monoclonal antibodyDrug

    Also called sintilimab

    Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 1

  • Definitive intensity-modulated radiotherapy (IMRT)Radiation

    Also called IMRT

    Definitive intensity-modulated radiotherapy (IMRT) of 50 Gy will be given in 25 days

Study groups in NCT04676789
Study groupRoleWhat they receive
Intervention/treatmentExperimentalPatients will receive sintilimab,200mg,ivdrip,day1; pegaspargase,2,500 unit/m2 deep intramuscular injection at three different sites,day 1, every 3 weeks for 4 cycles before radiation.Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent sintilimab of 200mg and pegaspargase,2,500 unit/m2 will be administered every 3 weeks for 2 cycles during IMRT for patients who do not achieve complete remission to previous induction therapy. After radiotherapy or CCRT, patients achieving CR with positive plasma EBV-DNA or partial response will continue with sintilimab maintenance up to 2 years.
Receives: Drug: Pegaspargase; Drug: Anti-PD-1 monoclonal antibody; Radiation: Definitive intensity-modulated radiotherapy (IMRT)

What is being measured

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

  1. progression free survival (PFS)

    Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy, or death from any cause, whichever occurred first.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

Secondary outcomes (6)

  1. complete remission (CR) rate

    Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy.

    Measured: At the end of Cycle 6 (each cycle is 21 days)

  2. overall response rate (ORR)

    Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy.

    Measured: At the end of Cycle 6 (each cycle is 21 days)

  3. overall survival (OS)

    Overall survival in the overall study population was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  4. Duration of response

    Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  5. EBV-DNA load change

    EBV-DNA load at each cycle for comparison

    Measured: At the end of Cycle 6 (each cycle is 21 days)

  6. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

Timeline

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

  1. First posted21 Dec 2020
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion31 Dec 2024 (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
Model description
treatment with sintilimab and pegaspargase combined with intensity-modulated radiotherapy (IMRT)
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04676789
Sponsor's protocol ID
SYSUCC-ENKTL-002
Acronym
SPENT
Status last verified
Dec 2020
First submitted
16 Dec 2020
Last updated
21 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegaspargase, Anti-PD-1 monoclonal antibody and Definitive intensity-modulated radiotherapy (IMRT) in people with Extranodal NK/T-cell Lymphoma, Nasal Type, 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Dec 2020. 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?

Results are not available in the source record.

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

Contact Hua Wang, MD. (0086-20-87342462, wanghua@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (PFS) (time frame: Baseline up to data cut-off (up to approximately 4 years)). 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 NCT04676789.

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 21 Dec 2020.

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