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Clinical Study of Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole

Primary Purpose

Aplastic Anemia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

levamisole hydrochloride

Androgens

Cyclosporins

About this trial

This is an interventional treatment trial for Aplastic Anemia focused on measuring Aplastic Anemia, levamisole hydrochloride, clinical study

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All the patients meet a NSAA diagnostic criteria, and agree the immunosuppressive therapy. Diagnoses reference to The diagnostic and therapeutic criteria for hematologic diseases（Zhang Zhinan 2007）, and The diagnosis and treatment of aplastic anemia（2016 UK guidelines）
18-70years old, male or female
Liver and kidney function: the blood bilirubin is less than or equal to 2mg/dL (35 mol/L), AST/ALT in the upper limit of the normal value below 2 times, blood inosine is less than or equal to 177 umol/L.
Heart function is normal: EF>50%.
No serious lung infection.
All cases had no history of cancer and chemotherapy history, immunology therapy. The control group without hematologic diseases, lupus or other immune disfunctions, allergic disease, Fanconi anemia.
Consent signed by patients or their families.

Exclusion Criteria:

Congenital hematopoietic failure, Fanconi anemia, or combined with bone marrow hyperplasia, leukemia, multiple myeloma, giant cell anemia, paroxysmal nocturnal hemoglobin or other blood diseases.
The HBV DNA copy number is greater than 1000/ml or the serum hepatitis B virus is not clear.
Serum bilirubin > 2mg/dL (35 umol/L); ALT or AST > 2 times the normal value of the upper limit; alkaline phosphatase > 3 times the upper limit of the normal value; serum creatinine > 177 mol/L.
HIV positive.
Other serious diseases that may limit the patient to participate in the study (e.g., the progressive infection, incontrollable diabetes, severe cardiac insufficiency or angina pectoris, etc.)
Conditions are not suitable for immunosuppressive therapy.
Pregnant or lactating women.
Can not understand or follow the research program.
Patients under 16 years of age.
Patients with a history of cancer, chemotherapy, or radiation therapy, immune system diseases or allergic diseases.

Sites / Locations

Zhejiang Province Traditional Chinese Medical HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

experimental group

control group

Arm Description

the patients treated with levamisole hydrochloride 150mg qod +androgens 80mg qd+cyclosporins 3-5mg/kg*d at least for one year

the patients treated without levamisole hydrochloride，but androgens 80mg qd+cyclosporins 3-5mg/kg*d at least for one year

Outcomes

Primary Outcome Measures

Routine blood test

hemoglobin；white blood cell；Platelet

Secondary Outcome Measures

Bone marrow

The proliferation of cells in bone marrow

biochemical test

Alanine aminotransferase；Aspartate aminotransferase

Full Information

NCT ID

NCT03218657

First Posted

June 16, 2017

Last Updated

July 24, 2017

Sponsor

Shengyun Lin

1. Study Identification

Unique Protocol Identification Number

NCT03218657

Brief Title

Clinical Study of Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole

Official Title

A Prospective, Randomized, Controlled Clinical Study of Non Transfusion Dependent Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole Hydrochloride

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Anticipated)

Primary Completion Date

July 1, 2019 (Anticipated)

Study Completion Date

July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shengyun Lin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The clinical symptoms of non transfusion dependent non severe aplastic anemia (NSAA) are often lighter than that of severe aplastic anemia. Clinical observation is often used and the treatment should be given according to the follow-up results of peripheral blood routine and the survival condition of the patients. In recent years, a number of studies at home or abroad have tended to intervene earlier. The risk of observation and waiting for disease progression is higher. Early immunosuppression should be considered. For the treatment of non transfusion dependent non severe aplastic anemia, the commonly used treatment regimen is androgen combined with CSA. But the investigators find that Levamisole hydrochloride (LMS) as a commonly used immunomodulatory drugs may be helpful to improving immune disorder symptoms in NSAA patients. Therefore,the investigators are conducting a prospective, randomized controlled study to compare the rate, side effects and long-term survival in non transfusion dependent patients with NSAA between the androgen+CSA group and the androgen+CSA+LMS group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aplastic Anemia

Keywords

Aplastic Anemia, levamisole hydrochloride, clinical study

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental group

Arm Type

Experimental

Arm Description

the patients treated with levamisole hydrochloride 150mg qod +androgens 80mg qd+cyclosporins 3-5mg/kg*d at least for one year

Arm Title

control group

Arm Type

Other

Arm Description

the patients treated without levamisole hydrochloride，but androgens 80mg qd+cyclosporins 3-5mg/kg*d at least for one year

Intervention Type

Drug

Intervention Name(s)

levamisole hydrochloride

Other Intervention Name(s)

levamisole

Intervention Description

levamisole hydrochloride take orally 150mg qod

Intervention Type

Drug

Intervention Name(s)

Androgens

Intervention Description

Androgens take orally 80mg qd

Intervention Type

Drug

Intervention Name(s)

Cyclosporins

Intervention Description

Cyclosporines take orally 3-5mg/kg*d qd

Primary Outcome Measure Information:

Title

Routine blood test

Description

hemoglobin；white blood cell；Platelet

Time Frame

up to 4 weeks

Secondary Outcome Measure Information:

Title

Bone marrow

Description

The proliferation of cells in bone marrow

Time Frame

1 year

Title

biochemical test

Description

Alanine aminotransferase；Aspartate aminotransferase

Time Frame

up to 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All the patients meet a NSAA diagnostic criteria, and agree the immunosuppressive therapy. Diagnoses reference to The diagnostic and therapeutic criteria for hematologic diseases（Zhang Zhinan 2007）, and The diagnosis and treatment of aplastic anemia（2016 UK guidelines） 18-70years old, male or female Liver and kidney function: the blood bilirubin is less than or equal to 2mg/dL (35 mol/L), AST/ALT in the upper limit of the normal value below 2 times, blood inosine is less than or equal to 177 umol/L. Heart function is normal: EF>50%. No serious lung infection. All cases had no history of cancer and chemotherapy history, immunology therapy. The control group without hematologic diseases, lupus or other immune disfunctions, allergic disease, Fanconi anemia. Consent signed by patients or their families. Exclusion Criteria: Congenital hematopoietic failure, Fanconi anemia, or combined with bone marrow hyperplasia, leukemia, multiple myeloma, giant cell anemia, paroxysmal nocturnal hemoglobin or other blood diseases. The HBV DNA copy number is greater than 1000/ml or the serum hepatitis B virus is not clear. Serum bilirubin > 2mg/dL (35 umol/L); ALT or AST > 2 times the normal value of the upper limit; alkaline phosphatase > 3 times the upper limit of the normal value; serum creatinine > 177 mol/L. HIV positive. Other serious diseases that may limit the patient to participate in the study (e.g., the progressive infection, incontrollable diabetes, severe cardiac insufficiency or angina pectoris, etc.) Conditions are not suitable for immunosuppressive therapy. Pregnant or lactating women. Can not understand or follow the research program. Patients under 16 years of age. Patients with a history of cancer, chemotherapy, or radiation therapy, immune system diseases or allergic diseases.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lin S Yun, master

Phone

13588887285

lsyww2003@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

shen y Ying, master

Phone

18368023551

413808426@qq.com

Facility Information:

Facility Name

Zhejiang Province Traditional Chinese Medical Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lin s Yun, master

Phone

13588887285

lsyww2003@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Clinical Study of Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole

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