Aplastic AnemiaNCT03218657
Clinical Study of Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole
A study testing levamisole hydrochloride, Androgens and Cyclosporins in people with Aplastic Anemia, run by Shengyun Lin at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aplastic Anemia
- What is being tested?
- levamisole hydrochloride, Androgens and Cyclosporins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Province Traditional Chinese Medical Hospital
Hangzhou, Zhejiang, 310006
Lin s Yun, master, 13588887285, lsyww2003@163.com
About this study
Official title: 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.
- Conditions
- Aplastic Anemia
- Being tested
- levamisole hydrochloride, Androgens, Cyclosporins
- Keywords
- Aplastic Anemia, levamisole hydrochloride, clinical study
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levamisole hydrochlorideDrug
Also called levamisole
levamisole hydrochloride take orally 150mg qod
AndrogensDrug
Androgens take orally 80mg qd
CyclosporinsDrug
Cyclosporines take orally 3-5mg/kg*d qd
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | the patients treated with levamisole hydrochloride 150mg qod +androgens 80mg qd+cyclosporins 3-5mg/kg*d at least for one year Receives: 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 Receives: Drug: Androgens; Drug: Cyclosporins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Routine blood test
hemoglobin；white blood cell；Platelet
Measured: up to 4 weeks
Secondary outcomes (2)
Bone marrow
The proliferation of cells in bone marrow
Measured: 1 year
biochemical test
Alanine aminotransferase；Aspartate aminotransferase
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aplastic AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengyun Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shengyun Lin, Zhejiang Provincial Hospital of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218657
- Sponsor's protocol ID
- AA-LSA/SA
- Status last verified
- Jul 2017
- First submitted
- 16 Jun 2017
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Clinical Study of Non Transfusion Dependent Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole Hydrochloride
- ClinicalTrials.gov ID
- NCT03218657
- Acronym / sponsor ID
- AA-LSA/SA
- Conditions
- Aplastic Anemia
- Keywords
- Aplastic Anemia, levamisole hydrochloride, clinical study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Shengyun LinUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: levamisole hydrochloride, Drug: Androgens, Drug: Cyclosporinsthe patients treated with levamisole hydrochloride 150mg qod +androgens 80mg qd+cyclosporins 3-5mg/kg*d at least for one year |
| control group | Other | Drug: Androgens, Drug: Cyclosporinsthe patients treated without levamisole hydrochloride，but androgens 80mg qd+cyclosporins 3-5mg/kg*d at least for one year |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levamisole hydrochlorideAlso: levamisolelevamisole hydrochloride take orally 150mg qod | Drug | experimental group |
| AndrogensAndrogens take orally 80mg qd | Drug | control group, experimental group |
| CyclosporinsCyclosporines take orally 3-5mg/kg*d qd | Drug | control group, experimental group |
Primary outcome
Routine blood test
Time frame: up to 4 weeks
hemoglobin；white blood cell；Platelet
2 secondary outcomes
Bone marrow
Time frame: 1 year
biochemical test
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing levamisole hydrochloride, Androgens and Cyclosporins in people with Aplastic Anemia, run by Shengyun Lin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin S Yun, master (13588887285, lsyww2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Routine blood test (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.