- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04676789
Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy in Early-Stage ENKTL (SPENT)
December 16, 2020 updated by: wanghua, Sun Yat-sen University
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.
Study Overview
Status
Not yet recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hua Wang, MD.
- Phone Number: 0086-20-87342462
- Email: wanghua@sysucc.org.cn
Study Locations
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Please Select
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Guangzhou, Please Select, China, 510060
- Sun Yat-sen University Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention/treatment
Patients 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.
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Pegaspargase 2500IU/m2 administered by intramuscular injection on Day 1
Other Names:
Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 1
Other Names:
Definitive intensity-modulated radiotherapy (IMRT) of 50 Gy will be given in 25 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression free survival (PFS)
Time Frame: Baseline up to data cut-off (up to approximately 4 years)
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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.
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Baseline up to data cut-off (up to approximately 4 years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: Baseline up to data cut-off (up to approximately 4 years)
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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.
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Baseline up to data cut-off (up to approximately 4 years)
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Duration of response
Time Frame: Baseline up to data cut-off (up to approximately 4 years)
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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.
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Baseline up to data cut-off (up to approximately 4 years)
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complete remission (CR) rate
Time Frame: At the end of Cycle 6 (each cycle is 21 days)
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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.
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At the end of Cycle 6 (each cycle is 21 days)
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overall response rate (ORR)
Time Frame: At the end of Cycle 6 (each cycle is 21 days)
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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.
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At the end of Cycle 6 (each cycle is 21 days)
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overall survival (OS)
Time Frame: Baseline up to data cut-off (up to approximately 4 years)
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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.
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Baseline up to data cut-off (up to approximately 4 years)
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EBV-DNA load change
Time Frame: At the end of Cycle 6 (each cycle is 21 days)
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EBV-DNA load at each cycle for comparison
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At the end of Cycle 6 (each cycle is 21 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hua Wang, MD., Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2021
Primary Completion (Anticipated)
September 1, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
December 16, 2020
First Submitted That Met QC Criteria
December 16, 2020
First Posted (Actual)
December 21, 2020
Study Record Updates
Last Update Posted (Actual)
December 21, 2020
Last Update Submitted That Met QC Criteria
December 16, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Lymphoma, Extranodal NK-T-Cell
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Antibodies
- Antibodies, Monoclonal
- Pegaspargase
Other Study ID Numbers
- SYSUCC-ENKTL-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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