Status:
UNKNOWN
Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL
Lead Sponsor:
Beijing Tongren Hospital
Conditions:
Extranodal NK/T-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 pu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04337593
Start Date
June 1 2020
End Date
December 31 2022
Last Update
April 7 2020
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