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A Pilot Study of Deferoxamine Before and During Myeloablative Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndromes or Acute Leukemia and Iron Overload


N/A
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome

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Trial Information

A Pilot Study of Deferoxamine Before and During Myeloablative Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndromes or Acute Leukemia and Iron Overload


See above


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.

Outcome Description:

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.

Outcome Time Frame:

Baseline , 6 month, 1 year

Safety Issue:

Yes

Principal Investigator

Philippe Armand, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

07-411

NCT ID:

NCT00658411

Start Date:

August 2008

Completion Date:

December 2011

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndrome
  • AML
  • ALL
  • MDS
  • iron overload
  • deferoxamine
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Iron Overload

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115