Acute Myeloid LeukemiaNCT00658411
Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation
A study testing deferoxamine in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- What is being tested?
- deferoxamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Pregnancy or inability or unwillingness to use contraception during the time of the study
- Lactating patients
- Inability to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this 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
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.
Read the detailed description
See above
- Being tested
- deferoxamine
- Keywords
- AML, ALL, MDS, iron overload, deferoxamine
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deferoxamineDrug
Also called Desferal, deferoxamine mesylate
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.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Deferoxamine for >=2 weeks prior to stem cells Receives: Drug: deferoxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline , 6 month, 1 year
Secondary outcomes (1)
1-year Post-Transplant Survival
Survival information for the 5 patients who were treated with deferoxamine was collected. This information was used to determine transplant-related mortality, relapse, disease-free and overall survival.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Closed due to slow patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Philippe Armand, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658411
- Sponsor's protocol ID
- 07-411
- Status last verified
- Apr 2013
- First submitted
- 31 Mar 2008
- Last updated
- 9 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22609885
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00658411
- Acronym / sponsor ID
- 07-411
- Keywords
- AML, ALL, MDS, iron overload, deferoxamine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to slow patient accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Aug 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Posted 9 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See above
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Drug: deferoxamineDeferoxamine for >=2 weeks prior to stem cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deferoxamineAlso: Desferal, deferoxamine mesylateGiven 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. | Drug | All patients |
Primary outcome
Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.
Time frame: Baseline , 6 month, 1 year
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.
1 secondary outcome
1-year Post-Transplant Survival
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22609885Armand 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Armand, MD, PhD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deferoxamine in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities. (time frame: Baseline , 6 month, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00658411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2013.