Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients
An Open Label, Safety and Tolerability Study of Deferasirox for Treatment of Transfusional Iron Overload in Low-risk and INT-1, Myelodysplastic Patients Using Serum Ferritin Monitoring
1 other identifier
interventional
176
2 countries
48
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2005
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2005
CompletedFirst Posted
Study publicly available on registry
May 5, 2005
CompletedStudy Start
First participant enrolled
July 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2008
CompletedResults Posted
Study results publicly available
August 16, 2021
CompletedAugust 16, 2021
July 1, 2021
2.7 years
May 4, 2005
May 11, 2021
July 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reporting Adverse Events
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the study, whether or not considered related to the participant's participation in the study. Serious Adverse Events include adverse events that result in either of death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect.
up to 53 Weeks
Secondary Outcomes (11)
Change in Serum Ferritin From Baseline to Weeks 13, 25, 37 and 53
From Baseline to Weeks 13, 25, 37 and 53
Change in Labile Plasma Iron (LPI)
From Baseline to Weeks 13, 25, 37 and 49
Directly Chelatable Iron (DCI)
From Baseline to Weeks 13, 25, 37 and 49
Total Iron Levels
From Baseline to Weeks 13, 25, 37, 49 and 53
Serum Transferrin Levels
From Baseline to Weeks 13, 25, 37, 49 and 53
- +6 more secondary outcomes
Study Arms (1)
ICL670
EXPERIMENTALEvaluate the safety and tolerability of deferasirox 20 mg/kg/day over one year in patients with MDS
Interventions
20 mg/kg/day over one year in patients with MDS
Eligibility Criteria
You may qualify if:
- Male or female patients with low or intermediate (INT-1) risk MDS
- Patients can be EITHER naĂ¯ve 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Univ of Alabama Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
Bay Area Cancer Research Group
Concord, California, 94520, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Cedars-Sinai Medical Center, UCLA School of Medicine
Los Angeles, California, 90048, United States
UCLA Medical Center
Los Angeles, California, 90095-1678, United States
UCSF
San Francisco, California, 94143-0324, United States
UCSF
San Francisco, California, 94143, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Emory University School of Medicine/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
Novartis Investigative Site
Chicago, Illinois, 60612, United States
University of Chicago Hospital
Chicago, Illinois, 60637-1470, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky College of Medicine, Markey Cancer Center
Lexington, Kentucky, 40536-0093, United States
Cabrini Center for Cancer Care/Christus St. Frances Cabrini Hospital
Alexandria, Louisiana, 71301, United States
St. Agnes HealthCare
Baltimore, Maryland, 21231-1000, United States
Rush Cancer Institute Univ. of Massachussets Medical Center
Worcester, Massachusetts, 01605, United States
Novartis Investigative Site
Southfield, Michigan, 48075, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
The Center for Cancer Care & Research (TCCCR)
St Louis, Missouri, 63110, United States
Oncology Hematology West, PC
Omaha, Nebraska, 68124-2346, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001, United States
The Cancer Center at Hackensack University
Hackensack, New Jersey, 07601, United States
NMOHC
Albuquerque, New Mexico, 87109, United States
Roswell Park Cancer Center
Buffalo, New York, 14623, United States
Rochester General Hospital/Lipson Cancer and Blood Center
Rochester, New York, 14621, United States
Cancer Care of WNC
Asheville, North Carolina, 28801, United States
Wake Forest UniversitComprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1082, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Novartis Investigative Site
Portland, Oregon, 97239, United States
Thomas Jefferson University; Jefferson Medical College, Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107, United States
Western Pennsylvania Hospital Cancer Institute
Pittsburgh, Pennsylvania, 15224, United States
The West Cancer Clinic
Memphis, Tennessee, 38120, United States
Novartis Investigative site
Nashville, Tennessee, 37232, United States
Baylor/The Methodist Hospital
Houston, Texas, 77030, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Arlington Fairfax Hematology Oncology PC
Arlington, Virginia, 22205, United States
Novartis Investigative Site
Spokane, Washington, 99202, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Novartis Investigative Site
Vancouver, British Columbia, V6Z 1Y6, Canada
Novartis Investigative Site
Hamilton, Ontario, L8N 3Z5, Canada
Novartis Investigative Site
Toronto, Ontario, M4N 3M5, Canada
Novartis Investigative Site
Toronto, Ontario, M5g 2M9, Canada
Novartis Investigative Site
Montreal, Quebec, H1T 2M4, Canada
Novartis Investigative Site
Montreal, Quebec, H2L 4M1, Canada
Related Publications (1)
List AF, Baer MR, Steensma DP, Raza A, Esposito J, Martinez-Lopez N, Paley C, Feigert J, Besa E. Deferasirox reduces serum ferritin and labile plasma iron in RBC transfusion-dependent patients with myelodysplastic syndrome. J Clin Oncol. 2012 Jun 10;30(17):2134-9. doi: 10.1200/JCO.2010.34.1222. Epub 2012 Apr 30.
PMID: 22547607RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2005
First Posted
May 5, 2005
Study Start
July 25, 2005
Primary Completion
March 28, 2008
Study Completion
March 28, 2008
Last Updated
August 16, 2021
Results First Posted
August 16, 2021
Record last verified: 2021-07