Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL

Extranodal NK/T-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04337593
• Other study ID #: TRhos-ENKTCL-4
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2020
• Source: Beijing Tongren Hospital
• Contact: Liang Wang, M.D.
• Phone: +8615001108693
• Email: wangliangtrhos[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extranodal NK/T-cell Lymphoma
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Drug:
• Basiliximab
20mg d1,8, repeated every 3 weeks
• Pegaspargase
2500IU/?, d1,repeated every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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