Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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See above

Conditions

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Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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All patients

Deferoxamine for \>=2 weeks prior to stem cells

Group Type EXPERIMENTAL

deferoxamine

Intervention Type DRUG

Given intravenously or subcutaneously over 8-12 hours daily for at least three weeks prior to transplantation date and continue until the day before the participant receives their donor's stem cells.

Interventions

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deferoxamine

Given intravenously or subcutaneously over 8-12 hours daily for at least three weeks prior to transplantation date and continue until the day before the participant receives their donor's stem cells.

Intervention Type DRUG

Other Intervention Names

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Desferal deferoxamine mesylate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No