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Anlotinib for Advanced and Refractory Natural Killer /T-cell Lymphoma | Clinical Trials | Clareo Health

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

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

NCT03618238•Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Xinhua Hospital

Shanghai, China

Key Dates

Start Date

July 25, 2018

Primary Completion Date

April 30, 2021

Completion Date

April 30, 2021

Last Updated

September 14, 2021

Enrollment

ACTUAL participants

Conditions

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

Interventions

Anlotinib

DRUG

Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma

NCT06376721

Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypeT-lymphoblastic Lymphoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 14, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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