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Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation

Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome

Intervention: deferoxamine (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Dana-Farber Cancer Institute

Official(s) and/or principal investigator(s):
Philippe Armand, MD, PhD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute


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.

Clinical Details

Official title: A Pilot Study of Deferoxamine Before and During Myeloablative Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndromes or Acute Leukemia and Iron Overload

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

Primary outcome: Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.

Secondary outcome: 1-year Post-Transplant Survival

Detailed description: See above


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- Lactating patients

- Inability to provide informed consent

Locations and Contacts

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Additional Information

Starting date: August 2008
Last updated: April 5, 2013

Page last updated: August 20, 2015

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