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

NCT03618238 | Completed Phase 2

• 1 other identifier: XHLSG-NK-1604
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

anlotinib; L-asparaginase resistant

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  The treatment response will be assessed every 12 weeks.

  12 weeks after the initiation of anlotinib treatment

Secondary Outcomes (1)

• Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  Day 1 of each course and then every 3 months for 2 years

Study Arms (1)

Anlotinib

EXPERIMENTAL

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

Drug: Anlotinib

Interventions

Anlotinib DRUG

12 mg daily for continus 14 days every 21 days

Also known as: Anlotinib Hydrochloride

Anlotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital

Shanghai, China

Location

MeSH Terms

Interventions

anlotinib

Study Officials

• Rong Tao, MD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and Associate Director of Department of Hematology

Model Details: drug

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 7, 2018
• Study Start: July 25, 2018
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)