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)

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Unknown; Phase 2

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

Treatments: Drug: Glucocorticoids; Drug: cyclosporin A+Glucocorticoids; Drug: Levamisole+cyclosporin A+Glucocorticoids

Study type: Interventional

Funder types: Other

Identifiers

NCT01760096

PNH-2013

Details and patient eligibility

About

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

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical and biochemical signs of Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes
2. Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data
3. patient should complete levamisole study for at least half a year

Exclusion criteria

1. Active infection which requires antibiotic treatment
2. Pregnant or lactating women
3. Epilepsy and mental illness
4. Kidney and liver function abnormal

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups

Levamisole+cyclosporin A+Glucocorticoids

Experimental group

Description:

Levamisole+cyclosporin A+Glucocorticoids

Treatment:

Drug: Levamisole+cyclosporin A+Glucocorticoids

cyclosporin A+Glucocorticoids

Active Comparator group

Description:

cyclosporin A+Glucocorticoids

Treatment:

Drug: cyclosporin A+Glucocorticoids

Glucocorticoids

Active Comparator group

Description:

Glucocorticoids

Treatment:

Drug: Glucocorticoids