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

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT03618238

Collaborator

(none)

Enrollment

Location

Arm

33.2

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type	Drug: Anlotinib	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

drugdrug

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 25, 2018

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anlotinib patients will be given anlotinib 12 mg daily for continus 14 days every 21 days until disease progression.	Drug: Anlotinib 12 mg daily for continus 14 days every 21 days Other Names: Anlotinib Hydrochloride

Arm

Intervention/Treatment

Experimental: Anlotinib

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

Drug: Anlotinib

12 mg daily for continus 14 days every 21 days

Other Names:

Anlotinib Hydrochloride

Outcome Measures

Primary Outcome Measures

Overall response rate [12 weeks after the initiation of anlotinib treatment]
The treatment response will be assessed every 12 weeks.

Secondary Outcome Measures

Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [Day 1 of each course and then every 3 months for 2 years]
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xinhua Hospital	Shanghai		China

Sponsors and Collaborators

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

Principal Investigator: Rong Tao, MD, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rong Tao, Clinical Professor and Associate Director of Department of Hematology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT03618238

Other Study ID Numbers:

XHLSG-NK-1604

First Posted:

Aug 7, 2018

Last Update Posted:

Sep 14, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rong Tao, Clinical Professor and Associate Director of Department of Hematology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

anlotinib

L-asparaginase resistant

Additional relevant MeSH terms:

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Study Results

No Results Posted as of Sep 14, 2021