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

This study has been terminated.

( Closed due to slow patient accrual )

First Received on March 31, 2008. Last Updated on January 19, 2012 History of Changes

Sponsor:	Dana-Farber Cancer Institute
Collaborator:	Brigham and Women's Hospital
Information provided by (Responsible Party):	Philippe Armand, MD, PhD, 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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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: Acute Lymphocytic Leukemia Acute Myeloid Leukemia Cancer Chronic Lymphocytic Leukemia Iron Leukemia Myelodysplastic Syndromes

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 ]

Enrollment:	4
Study Start Date:	August 2008
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (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.

Other Name: Desferal

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 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

Contacts and Locations

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

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
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:	Philippe Armand, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00658411 History of Changes
Other Study ID Numbers:	07-411
Study First Received:	March 31, 2008
Last Updated:	January 19, 2012
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
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Iron Overload
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Iron Metabolism Disorders
Metabolic Diseases
Deferoxamine
Siderophores
Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012