Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL

Phase 2

• Conditions: Extranodal NK/T-cell Lymphoma
• Interventions: Drug: Basiliximab; Drug: Pegaspargase

• Registration Number: NCT04337593
• Lead Sponsor: Beijing Tongren Hospital

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-04
• Study First Submitted QC: 2020-04-06
• Last Update Submitted: 2020-04-06
• Study First Posted: 2020-04-07
• Last Update Posted: 2020-04-07
• Study Start: 2020-06-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	Basiliximab	2500 IU/m2 pegaspargase given on day 1, 20 mg basiliximab given on day 1 and 8, repeated every 3 weeks
treatment arm	Pegaspargase	2500 IU/m2 pegaspargase given on day 1, 20 mg basiliximab given on day 1 and 8, repeated every 3 weeks

Primary Outcome Measures

Name	Time	Method
complete response rate	up to 15 weeks±1 week from start of treatment	evaluated by PET-CT scan or MRI, according to 2014 Lugano criteria for lymphoma

Secondary Outcome Measures

Name	Time	Method
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	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
overall response rate	up to 15 weeks±1 week from start of treatment	evaluated by PET-CT scan or MRI, according to 2014 Lugano criteria for lymphoma