Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Basiliximab in combination with pegaspargase in the treatment of relapsed/refractory NK/T-cell lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2020
CompletedFirst Posted
Study publicly available on registry
April 7, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 7, 2020
April 1, 2020
2 years
April 4, 2020
April 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complete response rate
evaluated by PET-CT scan or MRI, according to 2014 Lugano criteria for lymphoma
up to 15 weeks±1 week from start of treatment
Secondary Outcomes (2)
overall response rate
up to 15 weeks±1 week from start of treatment
one year progression free survival rate
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Study Arms (1)
treatment arm
EXPERIMENTAL2500 IU/m2 pegaspargase given on day 1, 20 mg basiliximab given on day 1 and 8, repeated every 3 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Pathology confirmed diagnosis of NK/T-cell lymphoma.
- Previously treated with pegaspargase-based regimens.
- PET-CT or MRI scan with at least one measurable lesion.
- ECOG score of 0-3 points.
- The lab tests within 1 week before enrollment meets the following:
- Blood routine: Hb≥80g/L, PLT≥50×10e9/L.
- Liver function: ALT, AST, TBIL≤2 times the upper limit of normal.
- Renal function: Cr is normal.
- Coagulation: plasma fibrinogen≥1.0g/L.
- Cardiac function: LVEF≥50%, ECG is normal
- Sign the informed consent form.
- Voluntary compliance with research protocols.
You may not qualify if:
- Patients with a history of pancreatitis.
- Active infection requires ICU treatment.
- Concomitant HIV infection or active infection with HBV, HCV.
- Serious complications such as fulminant DIC.
- Significant organ dysfunction:
- respiratory failure
- NYHA classification≥2 chronic congestive heart failure
- decompensation Hepatic or renal insufficiency
- high blood pressure and diabetes that cannot be controlled
- cerebral vascular events within the past 6 months.
- Pregnant and lactating women.
- Had a history of autoimmune diseases, and disease was active now. Those who were known to be allergic to drugs in the study regimen.
- Patients with other tumors who require treatments within 6 months.
- Other experimental drugs are being used.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Department of Hematology
Study Record Dates
First Submitted
April 4, 2020
First Posted
April 7, 2020
Study Start
June 1, 2020
Primary Completion
May 31, 2022
Study Completion
December 31, 2022
Last Updated
April 7, 2020
Record last verified: 2020-04