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

• Status: Completed
• Trial end date: 2018-02-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Deferasirox

Criteria

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