Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL

Capital Medical University

Status and phase: Unknown; Phase 2

Conditions: Extranodal NK/T-cell Lymphoma

Treatments: Drug: Basiliximab; Drug: Pegaspargase

Study type: Interventional

Funder types: Other

Identifiers

NCT04337593

TRhos-ENKTCL-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

treatment arm

Experimental group

Description:

2500 IU/m2 pegaspargase given on day 1, 20 mg basiliximab given on day 1 and 8, repeated every 3 weeks

Treatment:

Drug: Basiliximab

Drug: Pegaspargase