Aplastic Anemia Clinical Trial
Official title:
Observational Study of MRI Monitoring in Patients With Aplastic Anemia (AA) and Low or Int-1 Risk of Myelodysplastic Syndromes(MDS) Complicated With Iron Overload
Verified date | July 2016 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Observational |
The investigators aim to give an overview of Iron overload(IOL) of patients with AA and low and int-1 risk MDS and their sequelae under different chelation treatment. And the investigators also aim to evaluate the relationship of LIC and T2*/R2*.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | October 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Male or female of 18-80 year old. 2. With blood transfusion history or RBC-transfusion-dependence. 3. BM smear and biopsy plus chromosome analysis within 3 months before signing ICF, otherwise done during screening. 4. Excluding other diseases which might cause hematological abnormalities. 5. Serum ferritin level=500ng/ml with no sign of active infection or malignant disease. 6. Treatment with underlying disease is permitted for non-hematological and hematological conditions. 7. Previous iron chelation therapy like deferasirox or deferoxamine is permitted. 8. ECOG performance score =2 9. All subjects must: agree not to donate blood or be counseled about pregnancy precautions and risks of fetal exposure. 10. Written informed consent. Exclusion Criteria: 1. Patients who are under 18-year-old or over 80-year-old. 2. Prior history of other cancer unless cancer-free for =5 years. Subjects with the following history/concurrent conditions may enroll at any time: Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Prostate cancer stage-1 3. Proved HIV-1 infection 4. Active HBV or active HCV infection. 5. Pregnant or lactating 6. Patients unwilling to or unable to comply with the protocol. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | Novartis |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRI T2*/R2* for liver and heart | 3 years | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
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