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

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

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 Overview

• Status: Unknown
• Conditions: Aplastic Anemia
• Intervention / Treatment: Drug: levamisole hydrochloride; Drug: Androgens; Drug: Cyclosporins

• Study Type: Interventional
• Enrollment (Anticipated): 248
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lin s Yun, master; Phone Number: 13588887285; Email: lsyww2003@163.com
• Study Contact Backup: Name: shen y Ying, master; Phone Number: 18368023551; Email: 413808426@qq.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Zhejiang Province Traditional Chinese Medical Hospital
      • Contact: Lin s Yun, master; Phone Number: 13588887285; Email: lsyww2003@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: experimental group; the patients treated with levamisole hydrochloride 150mg qod +androgens 80mg qd+cyclosporins 3-5mg/kg*d at least for one year	Drug: levamisole hydrochloride; levamisole hydrochloride take orally 150mg qod; Other Names: levamisole; Drug: Androgens; Androgens take orally 80mg qd; Drug: Cyclosporins; Cyclosporines take orally 3-5mg/kg*d qd
OTHER: control group; the patients treated without levamisole hydrochloride，but androgens 80mg qd+cyclosporins 3-5mg/kg*d at least for one year	Drug: Androgens; Androgens take orally 80mg qd; Drug: Cyclosporins; Cyclosporines take orally 3-5mg/kg*d qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Routine blood test	hemoglobin；white blood cell；Platelet	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone marrow	The proliferation of cells in bone marrow	1 year
biochemical test	Alanine aminotransferase；Aspartate aminotransferase	up to 4 weeks

Collaborators and Investigators

• Sponsor: Shengyun Lin

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2018
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (ACTUAL): July 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: clinical study; Aplastic Anemia; levamisole hydrochloride
• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Bone Marrow Failure Disorders; Anemia; Anemia, Aplastic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Adjuvants, Immunologic; Antifungal Agents; Antiparasitic Agents; Antinematodal Agents; Anthelmintics; Calcineurin Inhibitors; Cyclosporine; Cyclosporins; Androgens; Levamisole
• Other Study ID Numbers: AA-LSA/SA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No