Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Conditions
Keywords
anlotinib, L-asparaginase resistant
Brief summary
The purpose of this study is to evaluate the efficacy and safety of anlotinib in patients with stage IV extranodal natural killer/T-cell lymphoma, nasal type.
Detailed description
Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. L-asparaginase based chemotherapy improved overall response and prolonged the long-term survival for patients with stage IV. But the treatment for the patients with advanced disease and resistant to L-asparaginase based chemotherapy has not been established. The overall survival for these patients are very poor. This study is designed to evaluate the efficacy and safety of anlotinib in patients with stage IV ENKTCL and refractory to L-asparaginase based chemotherapy.
Interventions
DRUGAnlotinib
12 mg daily for continus 14 days every 21 days
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
drug
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type. * stage IV disease and resistant to L-asparaginase-based combined chemotherapy.(Definition of L-asparaginase resistance: Progression during treatment or no response to treatment). * Eastern Cooperative Oncology Group (ECOG ) performance status 0\ 3. * Preserved organ functions for: absolute neutrophil counter (ANC)\>1.0×109/L, Platelet\>50×109/L, hemoglobin\>80g/L, total bilirubin (TBIL)\<2×ULN, alanine transaminase (ALT)\<2×ULN, normal serum creatinine，fibrinogen≥1.0g/L, LVEF≥50%. * Signed Informed consented.
Exclusion criteria
* patients with a disease resistant to L-asparaginase but may benefit from a radiotherapy. * HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥105 copies/ml. * Significant complications: autoimmune disease, severe infection, or liver cirrhosis, hemophagocytic lymphohistiocytosis, disseminated intravascular coagulation, uncontrolled hypertension or diabetes, hemorrhagic or thrombotic events within 6 months. * Mental disorders. * Pregnant or lactation * Peptic ulcer * Enrolled in other trial treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | 12 weeks after the initiation of anlotinib treatment | The treatment response will be assessed every 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Day 1 of each course and then every 3 months for 2 years | Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0. |
Countries
China
Outcome results
None listed