UnknownNot Applicable

Study of MRI Monitoring in Patients With Aplastic Anemia and Low or Int-1 Risk of MDS Complicated With Iron Overload

80 participantsStarted 2016-09

Plain-language summary

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\*.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Male or female of 18-80 year old.
✓. With blood transfusion history or RBC-transfusion-dependence.
✓. BM smear and biopsy plus chromosome analysis within 3 months before signing ICF, otherwise done during screening.
✓. Excluding other diseases which might cause hematological abnormalities.
✓. Serum ferritin level≥500ng/ml with no sign of active infection or malignant disease.
✓. Treatment with underlying disease is permitted for non-hematological and hematological conditions.
✓. Previous iron chelation therapy like deferasirox or deferoxamine is permitted.
✓. ECOG performance score ≤2

Exclusion criteria

✕. Patients who are under 18-year-old or over 80-year-old.
✕. Prior history of other cancer unless cancer-free for ≥5 years.
✕. Proved HIV-1 infection
✕. Active HBV or active HCV infection.
✕. Pregnant or lactating
✕. Patients unwilling to or unable to comply with the protocol.

What they're measuring

MRI T2*/R2* for liver and heart

Timeframe: 3 years

Trial details

NCT IDNCT02833493

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-09

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