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

Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618238
• Other study ID #: XHLSG-NK-1604
• Status: Completed
• Phase: Phase 2
• Start date: July 25, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Anlotinib
12 mg daily for continus 14 days every 21 days

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	The treatment response will be assessed every 12 weeks.	12 weeks after the initiation of anlotinib treatment
Secondary	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