Extranodal NK/T-cell Lymphoma
Conditions
Keywords
extranodal NK/T-cell lymphoma, basiliximab, pegaspargase, CD25
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.
Interventions
DRUGBasiliximab
20mg d1,8, repeated every 3 weeks
DRUGPegaspargase
2500IU/㎡, d1,repeated every 3 weeks
Sponsors
Beijing Tongren Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
all patients enrolled will received basiliximab and pegaspargase.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactLiang Wang, M.D.
Outcome results
None listed