CompletedPhase 2

Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study

United States, Australia, Bulgaria225 participantsStarted 2010-03-22

Plain-language summary

This was a randomized, double-blind trial to evaluate deferasirox vs placebo in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload .The trial was conducted in 17 countries, started in 2010 and ended in 2018.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Weigh between 35-135 kilograms * Low or int-1 risk MDS * Ferritin \>1000 micrograms/liter at screening * History of transfusion of 15 to 75 Packed Red Blood Cells (PRBC) units * Anticipated to be transfused with at least 8 units of PRBCs annually during the study * Women of child-bearing potential using effective methods of contraception during dosing of study treatment Exclusion Criteria: * More than 6 months of cumulative ICT (such as daily deferasirox (Exjade®) or deferiprone or 5×/week deferoxamine) * More than 3 years since patient began receiving regular transfusions (2 units per 8 weeks or 4 units received in a 3 month period) * Significant proteinuria * History of hospitalization for congestive heart failure; other heart conditions as specified in the protocol * Systemic diseases which would prevent study treatment * Hepatitis B; Hepatitis C; HIV * Liver cirrhosis * Pregnant, or breast-feeding patients, or patients of child-bearing potential not employing an effective method of birth control * History of drug or alcohol abuse within the 12 months prior to enrollment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Event-free Survival

Timeframe: Day 1 to end of treatment period, approx. 7 years

Trial details

NCT IDNCT00940602

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-02-27

Results submitted2019-02-25

View on ClinicalTrials.gov More Myelodysplastic Syndromes trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.