| March 31, 2008 |
| March 13, 2009 |
| August 2008 |
| April 2010 (final data collection date for primary outcome measure) |
| Grade 3 or above toxicity attributable to treatment drug [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00658411 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| Deferoxamine in Myeloablative Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndromes or Acute Leukemia and Iron Overload |
| A Pilot Study of Deferoxamine Before and During Myeloablative Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndromes or Acute Leukemia and Iron Overload |
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. |
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| |
| Interventional |
| Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Myelodysplastic Syndrome
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| Drug: deferoxamine mesylate |
| |
| |
| |
| Recruiting |
| 12 |
| April 2011 |
| April 2010 (final data collection date for primary outcome measure) |
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
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| Both |
| 18 Years and older |
| No |
| Contact: Philippe Armand, MD, PhD |
617-632-2305 |
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|
| Contact: Joanna Rhodes, MA |
617-632-5626 |
jrhodes4@partners.org |
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| United States |
| |
| NCT00658411 |
| Philippe Armand, MD, Ph.D, Dana-Farber Cancer Institute |
| 07-411 |
| Dana-Farber Cancer Institute |
| Brigham and Women's Hospital |
| Principal Investigator: |
Philippe Armand, MD, PhD |
Dana-Farber Cancer Institute |
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| Dana-Farber Cancer Institute |
| March 2009 |