NK/T Cell Lymphoma Nos
Conditions
Keywords
pegaspargase, sintilimab, PD-1, lenalidomide, relapsed/refractory
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with lenalidomide in the treatment of Relapsed/Refractory NK/T-cell lymphoma patients who failed pegaspargase-based regimens.
Detailed description
Pegaspargase is the backbone of treatment for NK/T-cell lymphoma (ENKTCL), and patients with ENKTCL who failed pegaspargase-based regimens have extremely poor survival outcomes. Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). Constitutive activation of NF-kB pathway has been demonstrated to be involved in the development of ENKTCL and plays critical role in therapy resistance. Lenalidomide, an immuno-modulatory drug, has been found to inhibit NF-kB pathway, and synergize with anti-PD-1 antibody in the treatment of multiple myeloma. Thus, we hypothesize that the combination of lenalidomide and sintilimab will further deepen the remission status and benefit patients who failed pegaspargase-based regimens.
Interventions
DRUGSintilimab
Sintilimab, 200mg, iv day1
DRUGLenalidomide
25mg/d oral d1-14
Sponsors
Beijing Tongren Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
treatment with lenalidomide in combination with sintilimab for relapsed/refractory ENKTCL patients
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria. * Previously treated with pegaspargase-based regimens (refractory or relapsed after initial remission). * PET/CT or CT/MRI with at least one objectively evaluable lesion. * General status ECOG score 0-3 points. * The laboratory test within 1 week before enrollment meets the following conditions: Blood routine: Hb\>80g/L, PLT\>50×10（9）/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 does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking. * Sign the informed consent form. * Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations.
Exclusion criteria
* Patients with a history of pancreatitis. * Active infection requires ICU treatment. * Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are not excluded. * Serious complications such as fulminant DIC. * Significant organ dysfunction: such as respiratory failure, NYHA classification ≥ 2 chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure and diabetes that cannot be controlled despite active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past 6 months. * Pregnant and lactating women. * Had a history of autoimmune diseases, and disease was active in the last 6 months, and was still taking oral immunosuppression in the past three months. * Those who were known to be allergic to drugs in the study regimen. * Patients with other tumors who require surgery or chemotherapy within 6 months. * Other experimental drugs are being used.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete response | 24 weeks ±7 days | evaluated by PET-CT and MRI, according to Lugano 2014 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of overall response | 24 weeks ±7 days | evaluated by PET-CT and MRI, according to Lugano 2014 criteria |
| 1-year progression free survival rate | up to 1year after enrollment | time from date of enrollment to date of disease progression, death of any reason, whichever comes first |
| 1-year overall survival rate | up to 1year after enrollment | time from date of enrollment to date of death of any reason |
| safety profiles | up to 1year after enrollment | according to CTCAE 4.0 |
Countries
China
Contacts
Primary ContactLIANG WANG, M.D.
Outcome results
None listed