Acute Myeloid LeukemiaNCT00954720
Observational Study of Iron Overload in Stem Cell Transplantation
An observational study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
Recent retrospective studies have suggested that iron overload is a clinically important problem in patients undergoing ablative stem cell transplantation. However, these studies relied on serum ferritin as a surrogate of iron overload, which limits the conclusions that can be drawn from such analyses. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient's who are 18 years or older with acute leukema or MDS underdoing a myeloablative allogeneic stem cell transplant
Who may be able to join
- Age ≥ 18 years.
- Histologically confirmed acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS)
- Planned allogeneic stem cell transplantation with myeloablative conditioning regimen (regardless of stem cell source or donor HLA match)
- Patients will be eligible even if they have had prior stem cell transplantation (autologous or allogeneic)
Who cannot join
- Contraindication to magnetic resonance imaging (MRI):
- Patients with cardiac pacemakers, implanted cardiac defibrillator (ICD), cardiac electrodes, pacing wires, internal electrodes, cochlear, otologic or other ear implants, metallic fragments or foreign body, metallic prosthesis. Patients with surgical staples should not be imaged until 7 days post-op unless approved by a radiologist;
- Severe claustrophobia
- Note: a history of allergic reaction to gadolinium is not a contraindication to enrollment, as contrast will not be used.
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Prospective Observational Study of Iron Overload in Patients With Acute Leukemia or Myelodysplastic Syndromes Undergoing Myeloablative Allogeneic Stem Cell Transplantation
Recent retrospective studies have suggested that iron overload is a clinically important problem in patients undergoing ablative stem cell transplantation. However, these studies relied on serum ferritin as a surrogate of iron overload, which limits the conclusions that can be drawn from such analyses. Therefore, the investigators are conducting a prospective study to more rigorously examine the prevalence, mechanisms, and consequences of iron overload in this patient population.
Read the detailed description
As above.
- Being tested
- No Intervention
- Keywords
- AML, ALL, MDS, iron overload
- 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.
No InterventionOther
There is no intervention on this trial
| Study group | Role | What they receive |
|---|---|---|
| Patient undergoing transplant | Patients with acute leukemia or MDS undergoing ablative stem cell transplantation. No intervention. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the prevalence of pre-transplantation iron overload (defined as liver iron content >2 mg/g dry weight by MRI) and of pre-transplantation severe iron overload (defined as liver iron content >7 mg/g dry weight by MRI)
Measured: Pre-transplant
Secondary outcomes (2)
To estimate the 6-month and 12-month prevalence of iron overload determined by liver MRI • To compare 6-month and 1-year TRM between patients with severe pre-transplantation iron overload (>7 mg/g dry weight) and those without.
Measured: 1 year post-transplant
To compare 6-month and 1-year TRM between patients with pre-transplantation serum ferritin > 2500 ng/ml and those with ferritin ≤ 2500 ng/ml.
Measured: 6 month and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startMar 2008
- Primary completionJan 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- 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
- NCT00954720
- Sponsor's protocol ID
- 07-413
- Status last verified
- Feb 2013
- First submitted
- 5 Aug 2009
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Iron Overload in Patients With Acute Leukemia or Myelodysplastic Syndromes Undergoing Myeloablative Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00954720
- Acronym / sponsor ID
- 07-413
- Keywords
- AML, ALL, MDS, iron overload
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent retrospective studies have suggested that iron overload is a clinically important problem in patients undergoing ablative stem cell transplantation. However, these studies relied on serum ferritin as a surrogate of iron overload, which limits the conclusions that can be drawn from such analyses. Therefore, the investigators are conducting a prospective study to more rigorously examine the prevalence, mechanisms, and consequences of iron overload in this patient population.
Detailed description
As above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing transplant | – | Other: No InterventionPatients with acute leukemia or MDS undergoing ablative stem cell transplantation. No intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient's who are 18 years or older with acute leukema or MDS underdoing a myeloablative allogeneic stem cell transplant
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Histologically confirmed acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS)
- Planned allogeneic stem cell transplantation with myeloablative conditioning regimen (regardless of stem cell source or donor HLA match)
- Patients will be eligible even if they have had prior stem cell transplantation (autologous or allogeneic)
Key exclusion criteria (5 listed)
- Contraindication to magnetic resonance imaging (MRI):
- Inability to provide informed consent
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 |
|---|---|---|
| No InterventionThere is no intervention on this trial | Other | Patient undergoing transplant |
Primary outcome
To estimate the prevalence of pre-transplantation iron overload (defined as liver iron content >2 mg/g dry weight by MRI) and of pre-transplantation severe iron overload (defined as liver iron content >7 mg/g dry weight by MRI)
Time frame: Pre-transplant
2 secondary outcomes
To estimate the 6-month and 12-month prevalence of iron overload determined by liver MRI • To compare 6-month and 1-year TRM between patients with severe pre-transplantation iron overload (>7 mg/g dry weight) and those without.
Time frame: 1 year post-transplant
To compare 6-month and 1-year TRM between patients with pre-transplantation serum ferritin > 2500 ng/ml and those with ferritin ≤ 2500 ng/ml.
Time frame: 6 month and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Dana-Farber Cancer Institute at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To estimate the prevalence of pre-transplantation iron overload (defined as liver iron content >2 mg/g dry weight by MRI) and of pre-transplantation severe iron overload (defined as liver iron content >7 mg/g dry weight by MRI) (time frame: Pre-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2013.