Deferoxamine in Myeloablative Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndromes or Acute Leukemia and Iron Overload

This study is currently recruiting participants.

Verified by Dana-Farber Cancer Institute, March 2009

First Received: March 31, 2008 Last Updated: March 13, 2009 History of Changes

Sponsor:	Dana-Farber Cancer Institute
Collaborator:	Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00658411

Purpose

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 1 to 3 months prior to transplantation and continuing through the preparative regimen.

Condition	Intervention
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome	Drug: deferoxamine mesylate

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Deferoxamine Deferoxamine mesylate

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

Grade 3 or above toxicity attributable to treatment drug [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To estimate 1-year transplant-related mortality, relapse, disease-free and overall survival in this cohort of patients. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To measure serum hepcidin levels in patients before and after transplantation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	August 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 or equal to 1500ng/ml (at the time of donor availability) and Liver iron content estimated greater than or equal to 7mg/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
Cardiac disease
Pregnancy or inability or unwillingness to use contraception during the time of the study
Lactating patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658411

Contacts

Contact: Philippe Armand, MD, PhD	617-632-2305
Contact: Joanna Rhodes, MA	617-632-5626	jrhodes4@partners.org

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators

Principal Investigator:

Philippe Armand, MD, PhD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Philippe Armand, MD, Ph.D )
Study ID Numbers:	07-411
Study First Received:	March 31, 2008
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00658411 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

AML
ALL
MDS
iron overload
deferoxamine

Additional relevant MeSH terms:

Leukemia, Lymphoid
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Iron Metabolism Disorders
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Pathologic Processes
Syndrome
Deferoxamine
Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Disease

Metabolic Diseases
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Iron Chelating Agents
Leukemia, Myeloid
Pharmacologic Actions
Siderophores
Lymphatic Diseases
Neoplasms
Chelating Agents
Iron Overload
Lymphoproliferative Disorders
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 27, 2009