Immune Disorders/Diseases
A Prospective, Non-Interventional Multicenter Registry in Iron Overloaded Lower-Risk Myelodysplastic Patients - CICL670AUS22
Description
The goal of this registry is to study the impact of iron overload and chelation on survival and organ function in MDS. The primary objective of this study is to evaluate the impact of chelation on overall survival (up to 5 years) in iron overloaded, lower risk MDS patients.
Inclusion Notes
Inclusion Criteria:
- Must be 18 years of age or greater.
- Lower-risk MDS classified according to FAB, WHO and/or IPSS criteria.
- FAB: RA, RARS, RAEB < 11% blasts
- WHO: RA (RS), RCMD (-RS), 5q-syndrome
- IPSS: Low and INT -1
- Transfusion/Serum ferritin requirements per protocol (at least one of the following criteria must be met:)
- > 20 cummulative units of packed red cells
- Ongoing transfusion requirement > 6 units every 12 weeks
- Serum ferritin > 1000ng/ml (samples must be obtained in the absence of concomitant infection and prior to a blood transfusion.)
- Approved and experimental MDS therapies are permitted.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Non-MDS life threatening conditions (life expectancy less than one year).
- Patient unwilling or unable to give consent.
Start Date
N/A