Clinical trial NCT00658411: Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Keywords: AML
ALL
MDS
iron overload
deferoxamine
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2008-04-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: See above

Eligibility criteria: 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

Primary outcomes:
measure: Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.
timeFrame: Baseline , 6 month, 1 year
Secondary outcomes:
measure: 1-year Post-Transplant Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Philippe Armand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Armand P, Sainvil MM, Kim HT, Rhodes J, Cutler C, Ho VT, Koreth J, Alyea EP, Neufeld EJ, Kwong RY, Soiffer RJ, Antin JH. Pre-transplantation iron chelation in patients with MDS or acute leukemia and iron overload undergoing myeloablative allo-SCT. Bone Marrow Transplant. 2013 Jan;48(1):146-7. doi: 10.1038/bmt.2012.94. Epub 2012 May 21. No abstract available.