Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation

NCT00658411 | Terminated Results DMC

• 1 other identifier: 07-411
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome

Keywords

AML; ALL; MDS; iron overload; deferoxamine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 1-year Post-Transplant Survival

  1 year

Study Arms (1)

All patients

EXPERIMENTAL

Deferoxamine for \>=2 weeks prior to stem cells

Drug: deferoxamine

Interventions

deferoxamine 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.

Also known as: Desferal, deferoxamine mesylate

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 22609885 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Iron Overload

Interventions

Deferoxamine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids

Limitations and Caveats

The number of patients enrolled on this study is far too small to draw reliable conclusions.

Results Point of Contact

• Title: Philippe Armand, MD, PhD
• Organization: Dana-Farber Cancer Institute

parmand@partners.org

617-632-2305

Study Officials

• Philippe Armand, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 15, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 9, 2013
• Results First Posted: April 9, 2013

Record last verified: 2013-04

Locations

US (2)