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)
Primary Purpose
Paroxysmal Nocturnal Hemoglobinuria, Hemoglobinuria, Hemoglobinuria, Paroxysmal
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Levamisole+cyclosporin A+Glucocorticoids
cyclosporin A+Glucocorticoids
Glucocorticoids
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Nocturnal Hemoglobinuria focused on measuring Paroxysmal Nocturnal Hemoglobinuria, Anemia, Hematologic Diseases, bone marrow failure, Immunologic Factors, Physiological Effects of Drugs, Levamisole, cyclosporine A
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
Sites / Locations
- Institute of Hematology & Blood Diseases Hospital,
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Levamisole+cyclosporin A+Glucocorticoids
cyclosporin A+Glucocorticoids
Glucocorticoids
Arm Description
Levamisole+cyclosporin A+Glucocorticoids
cyclosporin A+Glucocorticoids
Glucocorticoids
Outcomes
Primary Outcome Measures
Number of patients in each group in complete or partial remission
she got blood transfusion-independent,the hemoglobin became higher
Secondary Outcome Measures
Full Information
NCT ID
NCT01760096
First Posted
January 1, 2013
Last Updated
January 1, 2013
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT01760096
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Nocturnal Hemoglobinuria, Hemoglobinuria, Hemoglobinuria, Paroxysmal, Proteinuria, Urination Disorders, Thrombosis, Bone Marrow Failure, Aplastic Anemia,, Anemia, Hemolytic
Keywords
Paroxysmal Nocturnal Hemoglobinuria, Anemia, Hematologic Diseases, bone marrow failure, Immunologic Factors, Physiological Effects of Drugs, Levamisole, cyclosporine A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Levamisole+cyclosporin A+Glucocorticoids
Arm Type
Experimental
Arm Description
Levamisole+cyclosporin A+Glucocorticoids
Arm Title
cyclosporin A+Glucocorticoids
Arm Type
Active Comparator
Arm Description
cyclosporin A+Glucocorticoids
Arm Title
Glucocorticoids
Arm Type
Active Comparator
Arm Description
Glucocorticoids
Intervention Type
Drug
Intervention Name(s)
Levamisole+cyclosporin A+Glucocorticoids
Other Intervention Name(s)
Levamisole, cyclosporin A, Glucocorticoids
Intervention Description
Levamisole 2.5mg/kg every other day cyclosporin A 3-5mg/kg every other day Glucocorticoids0.25 mg/kg every day(prednisone)
Intervention Type
Drug
Intervention Name(s)
cyclosporin A+Glucocorticoids
Other Intervention Name(s)
cyclosporin A, Glucocorticoids
Intervention Description
cyclosporin A 3-5mg/kg every day Glucocorticoids0.25mg/kg every day(prednisone)
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids
Intervention Description
Glucocorticoids0.25mg/kg every day(prednisone)
Primary Outcome Measure Information:
Title
Number of patients in each group in complete or partial remission
Description
she got blood transfusion-independent,the hemoglobin became higher
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yizhou zheng, doctor
Organizational Affiliation
Institute of Hematology & Blood Diseases Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology & Blood Diseases Hospital,
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
16051736
Citation
Parker C, Omine M, Richards S, Nishimura J, Bessler M, Ware R, Hillmen P, Luzzatto L, Young N, Kinoshita T, Rosse W, Socie G; International PNH Interest Group. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005 Dec 1;106(12):3699-709. doi: 10.1182/blood-2005-04-1717. Epub 2005 Jul 28. No abstract available.
Results Reference
background
Links:
URL
http://www.chinablood.com.cn
Description
CBD
Learn more about this trial
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)
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