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

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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

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.
    



Study Type

Interventional


Primary Outcome

Routine blood test

Secondary Outcome

 Bone marrow

Condition

Aplastic Anemia

Intervention

levamisole hydrochloride

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

248

Start Date

January 1, 2018

Completion Date

July 1, 2022

Primary Completion Date

July 1, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. 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)

          2. 18-70years old, male or female

          3. 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.

          4. Heart function is normal: EF>50%.

          5. No serious lung infection.

          6. 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.

          7. Consent signed by patients or their families.

        Exclusion Criteria:

          1. Congenital hematopoietic failure, Fanconi anemia, or combined with bone marrow
             hyperplasia, leukemia, multiple myeloma, giant cell anemia, paroxysmal nocturnal
             hemoglobin or other blood diseases.

          2. The HBV DNA copy number is greater than 1000/ml or the serum hepatitis B virus is not
             clear.

          3. 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.

          4. HIV positive.

          5. 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.)

          6. Conditions are not suitable for immunosuppressive therapy.

          7. Pregnant or lactating women.

          8. Can not understand or follow the research program.

          9. Patients under 16 years of age.

         10. Patients with a history of cancer, chemotherapy, or radiation therapy, immune system
             diseases or allergic diseases.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, 13588887285, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03218657

Organization ID

AA-LSA/SA


Responsible Party

Sponsor-Investigator

Study Sponsor

Shengyun Lin


Study Sponsor

, , 


Verification Date

July 2017