Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation

Not Applicable

Terminated

Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome

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. 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 2 weeks to 3 months prior to transplantation and continuing through the preparative regimen.

Recruitment & Eligibility

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 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 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
Pregnancy or inability or unwillingness to use contraception during the time of the study
Lactating patients
Inability to provide informed consent

Arm && Interventions

Group	Intervention	Description
All patients	deferoxamine	Deferoxamine for \>=2 weeks prior to stem cells

Primary Outcome Measures

Name	Time	Method
Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.	Baseline , 6 month, 1 year	All patients meeting the criteria for Severe iron overload as defined by BOTH: ferritin ≥ 1000 ng/ml and liver iron content(LIC) ≥ 5 mg/gdw were enrolled and received chelation therapy with Deferoxamine. All patients who received chelation therapy were monitored for grade 3 or above toxicity Attributable to Deferoxamine(grades defined by the CTCAE Version 3). The number of participants with grade 3 or higher toxicities were measured and used to determine the safety of chelation therapy.

Secondary Outcome Measures

Name	Time	Method
1-year Post-Transplant Survival	1 year	Survival information for the 5 patients who were treated with deferoxamine was collected. This information was used to determine transplant-related mortality, relapse, disease-free and overall survival.

Locations (2): Dana-Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States