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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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