Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00658411
• Other study ID #: 07-411
• Status: Terminated
• Phase: N/A
• First received: March 31, 2008
• Last updated: April 5, 2013
• Start date: August 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2013
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Iron Overload
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.	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.	Baseline , 6 month, 1 year	Yes
Secondary	1-year Post-Transplant Survival	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.	1 year	No