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

NCT03218657 | Unknown

• 1 other identifier: AA-LSA/SA
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Aplastic Anemia

Keywords

Aplastic Anemia; levamisole hydrochloride; clinical study

Outcome Measures

Primary Outcomes (1)

• Routine blood test

  hemoglobin；white blood cell；Platelet

  up to 4 weeks

Secondary Outcomes (2)

• Bone marrow

  1 year

• biochemical test

  up to 4 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

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

Drug: levamisole hydrochloride; Drug: Androgens; Drug: Cyclosporins

control group

OTHER

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

Drug: Androgens; Drug: Cyclosporins

Interventions

levamisole hydrochloride DRUG

levamisole hydrochloride take orally 150mg qod

Also known as: levamisole

experimental group

Androgens DRUG

Androgens take orally 80mg qd

control group; experimental group

Cyclosporins DRUG

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

control group; experimental group

Eligibility Criteria

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

You may qualify if:

• 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）
• years 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengyun Lin: lead

Study Sites (1)

Zhejiang Province Traditional Chinese Medical Hospital

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Anemia, Aplastic

Interventions

Levamisole; Androgens; Cyclosporins

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Lin S Yun, master

CONTACT

13588887285; lsyww2003@163.com

shen y Ying, master

CONTACT

18368023551; 413808426@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: July 14, 2017
• Study Start: January 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2022
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

CN (1)