Clinical trial · Interventional
Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL
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
NCT04337593CI-TRIAL-00044516unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal NK/T-cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Basiliximab | Drug | — | UNRESOLVED |
| Pegaspargase | Drug | Pegaspargase | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment arm
- description
- 2500 IU/m2 pegaspargase given on day 1, 20 mg basiliximab given on day 1 and 8, repeated every 3 weeks
- interventionNames
- Drug: Basiliximab
- Drug: Pegaspargase
Primary outcomes (1)
- measure
- complete response rate
- timeFrame
- up to 15 weeks±1 week from start of treatment
- description
- evaluated by PET-CT scan or MRI, according to 2014 Lugano criteria for lymphoma
Secondary outcomes (2)
- measure
- overall response rate
- timeFrame
- up to 15 weeks±1 week from start of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.