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

• Status: Completed
• Trial end date: 2021-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Asparaginase

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