- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04096690
Anti-PD-1 Antibody Combined With Pegaspargase in the Treatment of Advanced Stage NK/T-cell Lymphoma
March 9, 2020 updated by: Zhao Weili, Ruijin Hospital
The Efficacy and Safety of Anti-PD-1 Antibody in Combination With Pegaspargase in the Treatment of Newly Diagnosed, Stage III to IV Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
This open-label, single arm study will evaluate the efficacy and safety of anti-PD-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage NK/T-cell lymphoma.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%~10%.
The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western countries, with poor prognosis.
L-asparaginase-based chemotherapy has improved the survival for these patients with advanced stage.
However, there is no standard of care for those patients with advanced stage.
Anti-PD-1 antibody has been proven its efficacy in relapsed or refractory NK/T cell lymphoma.
This open-label, single arm study will evaluate the efficacy and safety of PD-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage NK/T-cell lymphoma.
Study Type
Interventional
Enrollment (Anticipated)
22
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 Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200025
- Recruiting
- Ruijin Hospital
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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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pathologically confirmed NK/T cell lymphoma based on 2016 WHO classification
- Treatment naive
- Age > 18 years
- Advanced stage
- Must has measurable lesion in CT or PET-CT prior to treatment
- ECOG 0,1,2
- Informed consented
Exclusion Criteria:
- Aggressive NK/T-cell leukemia
- Has accepted PD-1,PD-L1 or PD-L2 antibody before
- Has accepted autologous Stem cell transplantation before
- History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- Primary CNS lymphoma
- Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/L ;Platelet<50*10^9/L; ALT or AST >3*ULN; Creatinine>2*ULN
- Other uncontrollable medical condition that may that may interfere the participation of the study
- Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation
- HIV infection
- HBV-DNA or HCV-RNA positive
- Diagnosed immunodeficiency or received systemic corticoid therapy 2 weeks prior to first dose.
- Received attenuated live vaccine 4 weeks prior to first dose.
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Anti-PD-1 antibody plus pegaspargase
Participants will receive induction treatment for six cycles of Anti-PD-1 antibody plus pegaspargase (21-day cycle) and Anti-PD-1 antibody monotherapy maintenance treatment for about 2 years (21-cycle)
|
Pegaspargase 3750IU administered by intramuscular injection on Day 1 of each 21-day cycle for 6 cycles in induction treatment
Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 2 of each 21-day cycle for 6 cycles in induction treatment Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 1 of each 21-day cycle for up to 28 cycles in maintenance treatment
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response rate
Time Frame: At the end of Cycle 6 (each cycle is 21 days)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: Baseline up to data cut-off (up to approximately 4 years)
|
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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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)
|
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)
|
Overall response rate
Time Frame: At the end of Cycle 6 (each cycle is 21 days)
|
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.
|
At the end of Cycle 6 (each cycle is 21 days)
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Progression free survival
Time Frame: Baseline up to data cut-off (up to approximately 4 years)
|
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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Duration of response
Time Frame: Baseline up to data cut-off (up to approximately 4 years)
|
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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EBV-DNA load change
Time Frame: End of induction treatment (approximately 1 year)
|
EBV-DNA load at each cycle for comparison
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End of induction treatment (approximately 1 year)
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Time Frame: Baseline (pre-dose [Hour 0] on Cycle1 Day1), Cycle3 Day 1, end of treatment (up to Month 6), every 3 months 1st year, every 6 months 2nd year, and 12 months thereafter up to data cut-off, up to approximately 4 years (cycle length = 21 days)
|
The EORTC QLQ-C30 is a health-related quality of life questionnaire.
A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.
|
Baseline (pre-dose [Hour 0] on Cycle1 Day1), Cycle3 Day 1, end of treatment (up to Month 6), every 3 months 1st year, every 6 months 2nd year, and 12 months thereafter up to data cut-off, up to approximately 4 years (cycle length = 21 days)
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Treatment related mortality
Time Frame: Baseline up to data cut-off (up to approximately 4 years)
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Percentage of death related with treatment on the basis of investigator assessments
|
Baseline up to data cut-off (up to approximately 4 years)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circulating free Deoxyribonucleic Acid (cfDNA) monitoring
Time Frame: Baseline up to data cut-off (up to approximately 4 years)
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CfDNA in peripheral blood assessed by local lab
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Baseline up to data cut-off (up to approximately 4 years)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ACTUAL)
September 10, 2019
Primary Completion (ANTICIPATED)
December 1, 2021
Study Completion (ANTICIPATED)
December 1, 2022
Study Registration Dates
First Submitted
September 18, 2019
First Submitted That Met QC Criteria
September 18, 2019
First Posted (ACTUAL)
September 20, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 11, 2020
Last Update Submitted That Met QC Criteria
March 9, 2020
Last Verified
March 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
- RJ-NK-2019
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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