Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study (TELESTO)
Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring TELESTO, MDS Study, Myelodysplastic Syndromes, Myelodysplastic Syndromes (low-int-1 risk)
Eligibility 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
Sites / Locations
- Pacific Cancer Medical Center, Inc. PAC Center
- Rocky Mountain Cancer Centers RMCC
- Willis-Knighton Cancer Center Dept of Onc
- Henry Ford Hospital Henry Ford
- Midwest Cancer Care Physicians MMCC
- Mercy Medical Research Institute SC
- Glacier View Research Institute - Cancer SC
- Hackensack University Medical Center Department of Research
- University of Texas MD Anderson Cancer Center Dept of MD Anderson (16)
- Cancer Care Centers of South Texas HOAST CCC of So.TX- MedicalCenter(2)
- Swedish Cancer Institute Ballard Campus
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Deferasirox
Placebo
10 mg/kg/day (once daily) for the first 2 weeks of treatment, followed by 20 mg/kg/day (once daily) from Week 2 to End of Treatment. After 3 months of treatment at 20 mg/kg/day, the dose was allowed to be adjusted by 5 or 10 mg/kg/day up to 40 mg/kg/day based on serum ferritin responses. When a target serum ferritin level was reached (usually between 500 and 1000 µg/L), the dose could be reduced by 50% to maintain the serum ferritin within the target range.
10 mg/kg/day (once daily) for the first 2 weeks of treatment, followed by 20 mg/kg/day (once daily) from Week 2 to End of Treatment. After 3 months of treatment at 20 mg/kg/day, the dose was allowed to be adjusted by 5 or 10 mg/kg/day up to 40 mg/kg/day based on serum ferritin responses. When a target serum ferritin level was reached (usually between 500 and 1000 µg/L), the dose could be reduced by 50% to maintain the serum ferritin within the target range.