Back to resultsAnlotinib for Advanced and Refractory Natural Killer /T-cell Lymphoma
Primary Purpose
Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type focused on measuring anlotinib, L-asparaginase resistant
Eligibility 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
Sites / Locations
- Xinhua Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anlotinib
Arm Description
patients will be given anlotinib 12 mg daily for continus 14 days every 21 days until disease progression.
Outcomes
Primary Outcome Measures
Overall response rate
The treatment response will be assessed every 12 weeks.
Secondary Outcome Measures
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Full Information
NCT ID
NCT03618238
First Posted
August 1, 2018
Last Updated
September 13, 2021
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03618238
Brief Title
Anlotinib for Advanced and Refractory Natural Killer /T-cell Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Keywords
anlotinib, L-asparaginase resistant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
drug
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anlotinib
Arm Type
Experimental
Arm Description
patients will be given anlotinib 12 mg daily for continus 14 days every 21 days until disease progression.
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Other Intervention Name(s)
Anlotinib Hydrochloride
Intervention Description
12 mg daily for continus 14 days every 21 days
Primary Outcome Measure Information:
Title
Overall response rate
Description
The treatment response will be assessed every 12 weeks.
Time Frame
12 weeks after the initiation of anlotinib treatment
Secondary Outcome Measure Information:
Title
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Description
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Time Frame
Day 1 of each course and then every 3 months for 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong Tao, MD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Anlotinib for Advanced and Refractory Natural Killer /T-cell Lymphoma
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