Clinical trial NCT03618238: Anlotinib for Advanced and Refractory Natural Killer /T-cell Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Keywords: anlotinib
L-asparaginase resistant
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: drug
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall response rate
timeFrame: 12 weeks after the initiation of anlotinib treatment
Secondary outcomes:
measure: Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Day 1 of each course and then every 3 months for 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Rong Tao, MD
role: PRINCIPAL_INVESTIGATOR
References: