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Status:

COMPLETED

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

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Myelodysplastic Syndrome

Iron Overload

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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.

Detailed Description

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 25 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 28 2008

Estimated Enrollment :

176 Patients enrolled

Trial Details

Trial ID

NCT00110266

Start Date

July 25 2005

End Date

March 28 2008

Last Update

August 16 2021

Active Locations (48)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 12 (48 locations)

1

Univ of Alabama Birmingham

Birmingham, Alabama, United States, 35294

2

Mayo Clinic

Phoenix, Arizona, United States, 85054

3

Bay Area Cancer Research Group

Concord, California, United States, 94520

4

City of Hope National Medical Center

Duarte, California, United States, 91010