Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL

Sponsor

Beijing Tongren Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04337593

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Extranodal NK/T-cell Lymphoma	Drug: Basiliximab Drug: Pegaspargase	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

all patients enrolled will received basiliximab and pegaspargase.all patients enrolled will received basiliximab and pegaspargase.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment arm 2500 IU/m2 pegaspargase given on day 1, 20 mg basiliximab given on day 1 and 8, repeated every 3 weeks	Drug: Basiliximab 20mg d1,8, repeated every 3 weeks Other Names: anti-CD25 antibody Drug: Pegaspargase 2500IU/㎡, d1,repeated every 3 weeks

Arm

Intervention/Treatment

Experimental: treatment arm

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

Drug: Basiliximab

20mg d1,8, repeated every 3 weeks

Other Names:

anti-CD25 antibody

Drug: Pegaspargase

2500IU/㎡, d1,repeated every 3 weeks

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.