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

Phase 2

Completed

• Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
• Interventions: Drug: Anlotinib

• Registration Number: NCT03618238
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2018-07-25
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-03
• Study First Posted: 2018-08-07
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anlotinib	Anlotinib	patients will be given anlotinib 12 mg daily for continus 14 days every 21 days until disease progression.

Primary Outcome Measures

Name	Time	Method
Overall response rate	12 weeks after the initiation of anlotinib treatment	The treatment response will be assessed every 12 weeks.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Xinhua Hospital; 🇨🇳 Shanghai, China