Status:
TERMINATED
Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. Patient...
Detailed Description
See above
Eligibility Criteria
Inclusion
- 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 1000ng/ml (at the time of donor availability) and Liver iron content estimated greater than or equal to 5mg/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
- 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
- Pregnancy or inability or unwillingness to use contraception during the time of the study
- Lactating patients
- Inability to provide informed consent
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00658411
Start Date
August 1 2008
End Date
December 1 2011
Last Update
April 9 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115