Status:
COMPLETED
Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This randomized, double blind trial to evaluate deferasirox vs placebo in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload consisted of four periods, a screenin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 22 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2018
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00940602
Start Date
March 22 2010
End Date
February 27 2018
Last Update
November 23 2020
Active Locations (71)
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1
Pacific Cancer Medical Center, Inc. PAC Center
Anaheim, California, United States, 92801
2
Rocky Mountain Cancer Centers RMCC
Greenwood Village, Colorado, United States
3
Willis-Knighton Cancer Center Dept of Onc
Shreveport, Louisiana, United States, 71103
4
Henry Ford Hospital Henry Ford
Detroit, Michigan, United States, 48202