Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation

Dana-Farber Cancer Institute

Status: Terminated

Conditions: Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Acute Myeloid Leukemia

Treatments: Drug: deferoxamine

Study type: Interventional

Funder types: Other

Identifiers

NCT00658411

07-411

Details and patient eligibility

About

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.

Full description

See above

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

All patients

Experimental group

Description:

Deferoxamine for \>=2 weeks prior to stem cells

Treatment:

Drug: deferoxamine