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

NCT02833493 | Unknown

• 1 other identifier: CICL670AAU05
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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\*.

Conditions

Aplastic Anemia; Dysmyelopoietic Syndromes; Iron Overload

Keywords

Magnetic Resonance Imaging; Iron overload; Iron chelation therapy; Follow-up

Outcome Measures

Primary Outcomes (1)

• MRI T2*/R2* for liver and heart

  3 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with AA or MDS with very good, good and intermediate risk as per IPSS-R who meet all the following criteria.

You may qualify if:

• 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
• All subjects must: agree not to donate blood or be counseled about pregnancy precautions and risks of fetal exposure.
• Written informed consent.

You may not qualify if:

• Patients who are under 18-year-old or over 80-year-old.
• 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
• Proved HIV-1 infection
• Active HBV or active HCV infection.
• Pregnant or lactating
• Patients unwilling to or unable to comply with the protocol.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Novartis: collaborator

MeSH Terms

Conditions

Anemia, Aplastic; Myelodysplastic Syndromes; Iron Overload

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Hematology

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 14, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 14, 2016

Record last verified: 2016-07