Anlotinib for Advanced and Refractory Natural Killer /T-cell Lymphoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of Anlotinib for the Evaluation of Safety and Efficacy in Patients With Stage IV Natural Killer/T-cell Lymphoma and Refractory to L-asparaginase Based Chemotherapy

Conditions
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Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Intervention / Treatment
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* Drug: Anlotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: drug
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anlotinib<br>patients will be given anlotinib 12 mg daily for continus 14 days every 21 days until disease progression. | Drug: Anlotinib<br>* 12 mg daily for continus 14 days every 21 days<br>* Other names: Anlotinib Hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | The treatment response will be assessed every 12 weeks. | 12 weeks after the initiation of anlotinib treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0. | Day 1 of each course and then every 3 months for 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anlotinib, L-asparaginase resistant