Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL

Study Overview
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Brief Summary
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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.

Detailed Description
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The investigators previously found that CD25 was elevated in patients who were resistant to chemotherapy, and CD25 can mediate resistance, which can be reversed by targeting CD25 therapy. Thus, 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.

Official Title
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Combination of Basiliximab and Pegaspargase in the Treatment of Relapsed/Refractory Extranodal NK/T-cell Lymphoma, Nasal Type: a Single Arm, Open Label, Phase 2 Trial

Conditions
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Extranodal NK/T-cell Lymphoma

Intervention / Treatment
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* Drug: Basiliximab
* Drug: Pegaspargase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: all patients enrolled will received basiliximab and pegaspargase.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>2500 IU/m2 pegaspargase given on day 1, 20 mg basiliximab given on day 1 and 8, repeated every 3 weeks | Drug: Basiliximab<br>* 20mg d1,8, repeated every 3 weeks<br>* Other names: anti-CD25 antibody;Drug: Pegaspargase<br>* 2500IU/㎡, d1,repeated every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall 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 | 
| one year progression free survival rate | Progression free survival was caculated from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CD25, extranodal NK/T-cell lymphoma, basiliximab, pegaspargase