- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01995331
Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300020
- Department of Pediatrics,Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Acquired Childhood Severe Aplastic Anemia (SAA)
Exclusion Criteria:
- not Childhood and Acquired Severe Aplastic Anemia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: moderate-dose cyclophosphomide
|
Drug,cyclophosphamide,cyclophosphamide (30 mg/kg/day) administered intravenously (IV) over 1 hr for 4 consecutive days Drug,cyclosporine A,5mg-12mg/kg.d,CSA was administered orally 40 days after the fourth dose of cyclophosphamide and maintained for 3 years. The dose of CSA was adjusted to maintain trough drug concentration above 150 μg/L and peak drug concentration above 300 μg/L. Drug, human granulocyte colony-stimulating factor (rhG-CSF), 5 μg/kg/day subcutaneously starting 24 hrs after the fourth dose of cyclophosphamide, and it was withdrawed when ANC was >1×109/L.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The reponse of Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
Time Frame: 36 months
|
Complete response (CR) was defined as achieving normal levels of hemoglobin adjusted for age, platelet count >100×109/L, and ANC>1.5×109/L.
Partial response (PR) was defined as transfusion independence, reticulocyte count >30×109/L, platelet count >30×109/L, and ANC >0.5×109/L above the baseline.
Persistence of transfusion requirement or death was evidence of no response (NR).
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The side effect of Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
Time Frame: 36 months
|
To report the death rate and the death cause , the infection rate and the pathogenic bacteria, especialy the fungal infection rate. To report other toxicity. |
36 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xiaifan Zhu, MD, Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bone Marrow Diseases
- Hematologic Diseases
- Bone Marrow Failure Disorders
- Anemia
- Anemia, Aplastic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclophosphamide
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- YL20102601
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aplastic Anemia
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSevere Aplastic Anemia | Idiopathic Aplastic Anemia | Moderate Aplastic Anemia Requiring Transfusions
-
University of UtahNovartisCompletedSevere Aplastic Anemia | Moderate Aplastic Anemia | Very Severe Aplastic AnemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingRecurrent Severe Aplastic Anemia | Refractory Severe Aplastic AnemiaUnited States
-
Peking University People's HospitalRecruiting
-
Boston Children's HospitalNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health... and other collaboratorsRecruitingSevere Aplastic AnemiaUnited States
-
Federal Research Institute of Pediatric Hematology...RecruitingAcquired Aplastic AnemiaRussian Federation
-
Shanghai General Hospital, Shanghai Jiao Tong University...Ruijin Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine and other collaboratorsCompleted
-
Nagoya UniversityUnknownAcquired Aplastic Anemia.Japan
-
Navy General Hospital, BeijingPeking Union Medical College Hospital; Cancer Institute and Hospital, Chinese... and other collaboratorsUnknownSevere Aplastic AnemiaChina
-
Jiangsu HengRui Medicine Co., Ltd.Recruiting
Clinical Trials on cyclophosphamide,cyclosporine A
-
AllerganCompletedDry Eye SyndromesUnited States
-
Sichuan UniversityUnknownMDS | Leukemia, AcuteChina
-
Assistance Publique - Hôpitaux de ParisCompletedCyclophosphamide Versus Anti-thymocyte Globulin for GVHD Prophylaxis After RIC Allo-SCT (ATG-CyGVHD)Graft vs Host DiseaseFrance
-
Institute of Rheumatology, PragueCharles University, Czech Republic; Palacky University; Ministry of Health, Czech... and other collaboratorsCompletedSystemic Lupus Erythematosus | Lupus NephritisCzech Republic
-
Zambon SpAEnrolling by invitationBronchiolitis Obliterans | Bronchiolitis Obliterans Syndrome | Obliterative BronchiolitisFrance, United States, Spain, Israel, Belgium, Denmark, Germany, United Kingdom, Austria
-
Bing HanCompletedPure Red Cell Aplasia, AcquiredChina
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedSevere Aplastic Anemia (SAA)United States
-
Masonic Cancer Center, University of MinnesotaRecruitingFollicular Lymphoma | Multiple Myeloma | Myelofibrosis | Lymphoblastic Lymphoma | Chronic Lymphocytic Leukemia | Lymphoplasmacytic Lymphoma | Non-Hodgkin Lymphoma | Mantle-Cell Lymphoma | Diffuse Large B Cell Lymphoma | Chronic Myelogenous Leukemia | Prolymphocytic Leukemia | Myelodysplasia | Acute Myeloid Leukemia... and other conditionsUnited States
-
University Hospital, RouenCompletedKidney Transplantation | Primary Prevention | Kidney Failure
-
LEO PharmaWithdrawnAtopic DermatitisNetherlands