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



Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/13/2017
Start Date:March 22, 2010
End Date:February 2, 2018

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A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of Deferasirox in Patients With Myelodysplastic Syndromes (Low/Int-1 Risk) and Transfusional Iron Overload

The primary purpose of this study is to prospectively assess the efficacy and safety of iron
chelation therapy with deferasirox compared to placebo in patients with myelodysplastic
syndromes (low/int-1 risk) and transfusional iron overload.


Inclusion Criteria:

- Males or females ≥ 18 years of age

- Patients must weigh between 35-135 kg MDS low -int-1 risk as determined by IPSS score
and confirmed by bone marrow examination within 6 months prior to study entry

- Ferritin> 1000 mcg/L at screening

- History of 15 to 75 PRBC transfusions

- Anticipated to be transfused at least 8 times annually during the study

Exclusion Criteria:

- More than 6 months of cumulative iron-chelation therapy (such as daily deferasirox
(Exjade) or deferiprone or 5x/week deferosamine). intermittent deferoxamine doses in
association with blood transfusions are not exclusionary regardless of duration of
such treatment.

-- More than 3 years since patient began receiving regular transfusions (2 units per 8
weeks or 4 units received in a 3 month period).

- Creatinine clearance < 40 ml/min

- Serum creatinine >1.5x ULN at screening

- Significant proteinuria: urinary protein/creatinine ratio >0.5 mg/mg in a non first
void urine sample

- ECOG performance status > 2

- Left ventricular ejection fraction < 50% by ECHO

- History of hospitalization for Congestive Heart Failure

- Systemic disease that would prevent study treatment (uncontrolled hypertension,
cardiovascular renal, hepatic (including Child-Pugh Class B and C) or metabolic
disease)

- Hepatitis B or C (HBsAg in the absences or HBsAB or HCV Ab positive with HCV RNA
positive)

- History of HIV positivity by (ELISA or Western blot)

- Treatment with systemic investigational drug within 4 weeks or topical investigational
drug within 7 days of study start

- ALT or AST > 3.5 x ULN at screening

- Total bilirubin > 1.5 x ULN at screening

- Diagnosis of liver cirrhosis

- Patient participating in another clinical trial or receiving an investigational drug

- History of another malignancy within the past five years, with the exception of basal
skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps
carcinoma in situ

- History of non-compliance with medical regimen, or patients potentially unreliable
and/or not cooperative

- Presence of surgical or medical condition which might significantly alter the
absorption, distribution, metabolism or excretion of study drug

- Pregnant or intending to become pregnant or breast-feeding patents

- History of drug or alcohol abuse within the 12 months prior to enrollment.

- Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
18
sites
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Anaheim, CA
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Chicago, IL
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Denton, Texas 76210
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from
Denton, TX
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Detroit, Michigan 48202
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Detroit, MI
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Greenwood Village, Colorado
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Greenwood Village, CO
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from
Hackensack, NJ
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Herston, Queensland
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from
Herston,
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from
Houston, TX
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from
Kalispell, MT
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Kansas City, Missouri 64131
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from
Kansas City, MO
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from
Las Vegas, NV
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from
Los Angeles, CA
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Manchester, Missouri 63021
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from
Manchester, MO
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from
San Antonio, TX
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Seattle, Washington 98107
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from
Seattle, WA
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Shreveport, Louisiana 71103
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from
Shreveport, LA
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from
Troy, NY
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from
Yakima, WA
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