Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL

NCT ID: NCT04337593

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-12-31

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.

Conditions

Extranodal NK/T-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment arm

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

Group Type: EXPERIMENTAL

Basiliximab

Intervention Type: DRUG

20mg d1,8, repeated every 3 weeks

Pegaspargase

Intervention Type: DRUG

2500IU/㎡, d1,repeated every 3 weeks

Interventions

Basiliximab

20mg d1,8, repeated every 3 weeks

Intervention Type: DRUG

Pegaspargase

2500IU/㎡, d1,repeated every 3 weeks

Intervention Type: DRUG

Other Intervention Names

anti-CD25 antibody

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

LIANG WANG

Professor of Department of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Liang Wang, M.D.

Role: CONTACT

wangliangtrhos@126.com

+8615001108693

Other Identifiers

TRhos-ENKTCL-4

Identifier Type: -

Identifier Source: org_study_id