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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome, Iron Overload

Thank you

Trial Information

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


Study entry requires a diagnosis of low or intermediate (INT-1) risk MDS per International
Prognostic Scoring System (IPSS) criteria and serum ferritin ≥ 1000 ng/mL. Patients must
have had at least 30 prior red blood cell transfusions. Deferasirox will be administered at
an initial dose of 20 mg/kg orally once per day. Patient transfusion history and at least
three complete blood count (CBC) values must be available for the 12 weeks prior to study
registration for patients with MDS and chronic iron overload from blood transfusions.


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

- 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)

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

12 month safety in patients with myelodysplastic syndrome (MDS)

Outcome Time Frame:

throughout the study

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CICL670AUS03

NCT ID:

NCT00110266

Start Date:

May 2005

Completion Date:

March 2010

Related Keywords:

  • Myelodysplastic Syndrome
  • Iron Overload
  • ICL670
  • Deferasirox
  • Iron chelation
  • Chelator
  • Desferal
  • Myelodysplastic Syndromes
  • Preleukemia
  • Iron Overload

Name

Location

UCSFSan Francisco, California  941430324
Mayo ClinicRochester, Minnesota  55905
Medical College of WisconsinMilwaukee, Wisconsin  53226
University of Kansas Medical CenterKansas City, Kansas  66160-7353
City of Hope National Medical CenterLos Angeles, California  91010
Mayo ClinicJacksonville, Florida  32224
Rocky Mountain Cancer CentersThornton, Colorado  80260
St. Agnes HealthcareBaltimore, Maryland  21229
The Ohio State UniversityColumbus, Ohio  43210
Straub Clinic and HospitalHonolulu, Hawaii  96813
UCLA Medical CenterLos Angeles, California  90095-7059
Roswell Park Cancer CenterBuffalo, New York  14263
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
Mayo ClinicScottsdale, Arizona  
The Cleveland Clinic FoundationCleveland, Ohio  
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Bay Area Cancer Research GroupConcord, California  94520
The West Cancer ClinicMemphis, Tennessee  38120
Cancer Care of WNCAsheville, North Carolina  28801
Univ of Alabama BirminghamBirmingham, Alabama  35294
Cedars-Sinai Medical Center, UCLA School of MedicineLos Angeles, California  90048
Emory University School of Medicine/Winship Cancer InstituteAtlanta, Georgia  30322
University of Chicago HospitalChicago, Illinois  60637-1470
Novartis Investigative SiteChicago, Illinois  60612
University of Kentucky College of Medicine, Markey Cancer CenterLexington, Kentucky  40536-0093
Cabrini Center for Cancer Care/Christus St. Frances Cabrini HospitalAlexandria, Louisiana  71301
Rush Cancer Institute Univ. of Massachussets Medical CenterWorchester, Massachusetts  01605
Novartis Investigative SiteSouthfield, Michigan  48075
The Center for Cancer Care & Research (TCCCR)St. Louis, Missouri  63110
Oncology Hematology West, PCOmaha, Nebraska  68124-2346
The Cancer Center at Hackensack UniversityHackensack, New Jersey  07601
NMOHCAlbuquerque, New Mexico  87109
Rochester General Hospital/Lipson Cancer and Blood CenterRochester, New York  14621
Wake Forest UniversitComprehensive Cancer CenterWinston Salem, North Carolina  27157-1082
Novartis Investigative SitePortland, Oregon  97239
Thomas Jefferson University; Jefferson Medical College, Kimmel Cancer CenterPhiladelphia, Pennsylvania  19107
Western Pennsylvania Hospital Cancer InstitutePittsburgh, Pennsylvania  15224
Novartis Investigative siteNashville, Tennessee  37232
Baylor/The Methodist HospitalHouston, Texas  77030
Arlington Fairfax Hematology Oncology PCArlington, Virginia  22205
Novartis Investigative SiteSpokane, Washington  99202