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

Completed · Phase 2 · Has a placebo group

Conditions studied: Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID

NCT00940602

Run by

Novartis Pharmaceuticals

People needed

225

Starts

2010-03-22

Expected to finish

2018-02-27

Last updated by the study team

2020-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rocky Mountain Cancer Centers RMCC — Greenwood Village, Colorado, United States
• Willis-Knighton Cancer Center Dept of Onc — Shreveport, Louisiana, United States
• Henry Ford Hospital Henry Ford — Detroit, Michigan, United States
• Midwest Cancer Care Physicians MMCC — Kansas City, Missouri, United States
• Mercy Medical Research Institute SC — Manchester, Missouri, United States
• Glacier View Research Institute - Cancer SC — Kalispell, Montana, United States
• Hackensack University Medical Center Department of Research — Hackensack, New Jersey, United States
• University of Texas MD Anderson Cancer Center Dept of MD Anderson (16) — Houston, Texas, United States
• Cancer Care Centers of South Texas HOAST CCC of So.TX- MedicalCenter(2) — San Antonio, Texas, United States
• Swedish Cancer Institute Ballard Campus — Seattle, Washington, United States
• Novartis Investigative Site — Herston, Queensland, Australia
• Novartis Investigative Site — Plovdiv, Bulgaria
• Novartis Investigative Site — Sofia, Bulgaria
• Novartis Investigative Site — Varna, Bulgaria
• Novartis Investigative Site — Edmonton, Alberta, Canada
• Novartis Investigative Site — Winnipeg, Manitoba, Canada
• Novartis Investigative Site — Brampton, Ontario, Canada
• Novartis Investigative Site — St. Catharines, Ontario, Canada
• Novartis Investigative Site — Québec, Quebec, Canada
• Novartis Investigative Site — Guangzhou, Guangdong, China
• Novartis Investigative Site — Wuhan, Hubei, China
• Novartis Investigative Site — Nanjing, Jiangsu, China
• Novartis Investigative Site — Suzhou, Jiangsu, China
• Novartis Investigative Site — Shanghai, Shanghai Municipality, China
• Pacific Cancer Medical Center, Inc. PAC Center — Anaheim, California, United States

Full record on ClinicalTrials.gov

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