Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients

Completed · Phase 2

Conditions studied: Myelodysplastic Syndrome, Iron Overload

In brief

The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.

Key facts

Study ID

NCT00110266

Run by

Novartis Pharmaceuticals

People needed

176

Starts

2005-07-25

Expected to finish

2008-03-28

Last updated by the study team

2021-08-16

Who can join

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

You may qualify if…

• Male or female patients with low or intermediate (INT-1) risk MDS
• Patients can be EITHER naïve to iron chelation OR have had prior treatment with deferoxamine (DFO).
• Age greater than or equal to 18 years
• Availability of transfusion records for the 12 weeks prior to registration
• A lifetime minimum of 30 previous packed red blood cell transfusions
• Availability of at least three CBC values (pretransfusion) during the 12 weeks prior to registration
• Serum Ferritin:
• For entry into the screening period, serum ferritin ≥ 1000 ng/mL on at least two occasions, at least two weeks apart, during the prior year.
• Serum ferritin ≥ 1000 ng/mL at screening via the central lab.
• Life expectancy ≥ 6 months
• Sexually active women must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months)
• Able to provide written informed consent

You may not qualify if…

• Serum creatinine above the upper limit of normal
• Alanine aminotransferase (ALT) > 500 U/L during screening
• Clinical or laboratory evidence of active Hepatitis B or C
• Urinary protein/creatinine ratio > 0.5 mg/mg
• History of HIV positive test result (ELISA or Western blot)
• Eastern Cooperative Oncology Group (ECOG) Performance Status > 2
• Patients with uncontrolled systemic hypertension
• Unstable cardiac disease not controlled by standard medical therapy
• Patients with a diagnosis of or history of clinically relevant ocular toxicity related to iron chelation
• Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
• Pregnancy or breast feeding
• Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days
• Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
• History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative

Where it is running

• Univ of Alabama Birmingham — Birmingham, Alabama, United States
• Mayo Clinic — Phoenix, Arizona, United States
• Bay Area Cancer Research Group — Concord, California, United States
• City of Hope National Medical Center — Duarte, California, United States
• Cedars-Sinai Medical Center, UCLA School of Medicine — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• UCSF — San Francisco, California, United States
• UCSF — San Francisco, California, United States
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Emory University School of Medicine/Winship Cancer Institute — Atlanta, Georgia, United States
• Straub Clinic and Hospital — Honolulu, Hawaii, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• University of Chicago Hospital — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky College of Medicine, Markey Cancer Center — Lexington, Kentucky, United States
• Cabrini Center for Cancer Care/Christus St. Frances Cabrini Hospital — Alexandria, Louisiana, United States
• St. Agnes HealthCare — Baltimore, Maryland, United States
• Rush Cancer Institute Univ. of Massachussets Medical Center — Worcester, Massachusetts, United States
• Novartis Investigative Site — Southfield, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• The Center for Cancer Care & Research (TCCCR) — St Louis, Missouri, United States
• Oncology Hematology West, PC — Omaha, Nebraska, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• The Cancer Center at Hackensack University — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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