Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)

Study Overview
=================
Brief Summary
-----------------
Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes

Detailed Description
-----------------
Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired clonal disorder of the hematopoietic stem cell characterized by intravascular hemolysis, hemoglobinuria, anemia, and thrombosis, Patients may be at high risk of thrombosis and may develop bone marrow failure or aplastic anemia, with low white blood cell and platelet counts,because the manifestation and pathologic processes are complicate,the treatment is very difficult,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes

Official Title
-----------------
Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)

Conditions
-----------------
Paroxysmal Nocturnal Hemoglobinuria, Hemoglobinuria, Hemoglobinuria, Paroxysmal, Proteinuria, Urination Disorders, Thrombosis, Bone Marrow Failure, Aplastic Anemia,, Anemia, Hemolytic

Intervention / Treatment
-----------------
* Drug: Levamisole+cyclosporin A+Glucocorticoids
* Drug: cyclosporin A+Glucocorticoids
* Drug: Glucocorticoids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical and biochemical signs of Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data patient should complete levamisole study for at least half a year Exclusion Criteria: Active infection which requires antibiotic treatment Pregnant or lactating women Epilepsy and mental illness Kidney and liver function abnormal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levamisole+cyclosporin A+Glucocorticoids<br>Levamisole+cyclosporin A+Glucocorticoids | Drug: Levamisole+cyclosporin A+Glucocorticoids<br>* Levamisole 2.5mg/kg every other day cyclosporin A 3-5mg/kg every other day Glucocorticoids0.25 mg/kg every day(prednisone)<br>* Other names: Glucocorticoids;|
| Active Comparator: cyclosporin A+Glucocorticoids<br>cyclosporin A+Glucocorticoids | Drug: cyclosporin A+Glucocorticoids<br>* cyclosporin A 3-5mg/kg every day Glucocorticoids0.25mg/kg every day(prednisone)<br>* Other names: Glucocorticoids;|
| Active Comparator: Glucocorticoids<br>Glucocorticoids | Drug: Glucocorticoids<br>* Glucocorticoids0.25mg/kg every day(prednisone)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients in each group in complete or partial remission | she got blood transfusion-independent,the hemoglobin became higher | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paroxysmal Nocturnal Hemoglobinuria, Anemia, Hematologic Diseases, bone marrow failure, Immunologic Factors, Physiological Effects of Drugs, Levamisole, cyclosporine A