Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients
Myelodysplastic Syndrome, Iron Overload
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring ICL670, Deferasirox, Iron chelation, Chelator, Desferal
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Univ of Alabama Birmingham
- Mayo Clinic
- Bay Area Cancer Research Group
- City of Hope National Medical Center
- Cedars-Sinai Medical Center, UCLA School of Medicine
- UCLA Medical Center
- UCSF
- UCSF
- Rocky Mountain Cancer Centers
- Mayo Clinic
- Emory University School of Medicine/Winship Cancer Institute
- Straub Clinic and Hospital
- Novartis Investigative Site
- University of Chicago Hospital
- University of Kansas Medical Center
- University of Kentucky College of Medicine, Markey Cancer Center
- Cabrini Center for Cancer Care/Christus St. Frances Cabrini Hospital
- St. Agnes HealthCare
- Rush Cancer Institute Univ. of Massachussets Medical Center
- Novartis Investigative Site
- Mayo Clinic
- The Center for Cancer Care & Research (TCCCR)
- Oncology Hematology West, PC
- Dartmouth Hitchcock Medical Center
- The Cancer Center at Hackensack University
- NMOHC
- Roswell Park Cancer Center
- Rochester General Hospital/Lipson Cancer and Blood Center
- Cancer Care of WNC
- Wake Forest UniversitComprehensive Cancer Center
- The Cleveland Clinic Foundation
- The Ohio State University
- Novartis Investigative Site
- Thomas Jefferson University; Jefferson Medical College, Kimmel Cancer Center
- Western Pennsylvania Hospital Cancer Institute
- The West Cancer Clinic
- Novartis Investigative site
- Baylor/The Methodist Hospital
- Utah Cancer Specialists
- Arlington Fairfax Hematology Oncology PC
- Novartis Investigative Site
- Medical College of Wisconsin
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Experimental
ICL670
Evaluate the safety and tolerability of deferasirox 20 mg/kg/day over one year in patients with MDS