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Deferoxamine in Myeloablative Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndromes or Acute Leukemia and Iron Overload
This study is currently recruiting participants.
Study NCT00658411   Information provided by Dana-Farber Cancer Institute
First Received: March 31, 2008   Last Updated: March 13, 2009   History of Changes

March 31, 2008
March 13, 2009
August 2008
April 2010   (final data collection date for primary outcome measure)
Grade 3 or above toxicity attributable to treatment drug [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00658411 on ClinicalTrials.gov Archive Site
  • To estimate 1-year transplant-related mortality, relapse, disease-free and overall survival in this cohort of patients. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To measure serum hepcidin levels in patients before and after transplantation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
 
Deferoxamine in Myeloablative Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndromes or Acute Leukemia and Iron Overload
A Pilot Study of Deferoxamine Before and During Myeloablative Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndromes or Acute Leukemia and Iron Overload

The objective of this research study is to determine the safety and feasibility of chelation therapy with deferoxamine for patients with iron overload who are receiving a stem cell transplant. Patients who have iron overload prior to stem cell transplantation may have more toxicity from the transplantation procedure, and thus may benefit from an attempt at iron chelation pre- and peri-transplantation. In this study we are examining the use of deferoxamine starting 1 to 3 months prior to transplantation and continuing through the preparative regimen.

 
 
Interventional
Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndrome
Drug: deferoxamine mesylate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
12
April 2011
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older
  • Histologically confirmed acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome
  • Planned allogeneic stem cell transplantation with myeloablative conditioning regimen; the planned date of transplantation must be at least 4 weeks from time of enrollment
  • Severe iron overload as defined by BOTH: Ferritin greater than or equal to 1500ng/ml (at the time of donor availability) and Liver iron content estimated greater than or equal to 7mg/g dry weight by MRI (at the time of donor availability)
  • Patients with a history of prior autologous transplantation will be eligible for this study

Exclusion Criteria:

  • Contraindication to magnetic resonance imaging (MRI)
  • Creatinine >2.0mg/dl or creatinine clearance <50ml/min
  • Active uncontrolled bacterial or fungal infection
  • History of mucormycosis
  • Pre-existing clinically apparent retinal neuropathy. If patients have clinically apparent visual loss at the time of screening, they will be excluded if either they have known retinal neuropathy or if this cannot be excluded by further testing
  • Pre-existing clinically apparent sensorineural hearing loss. If patients have auditory loss at the time of screening, they will be excluded if either they have known sensorineural hearing loss, or if this cannot be excluded by further testing
  • Cardiac disease
  • Pregnancy or inability or unwillingness to use contraception during the time of the study
  • Lactating patients
Both
18 Years and older
No
Contact: Philippe Armand, MD, PhD 617-632-2305
Contact: Joanna Rhodes, MA 617-632-5626 jrhodes4@partners.org
United States
 
NCT00658411
Philippe Armand, MD, Ph.D, Dana-Farber Cancer Institute
07-411
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Philippe Armand, MD, PhD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP