CancerNCT00888316
Iron Overload in Patients Undergoing Donor Stem Cell Transplant
An observational study of Cancer and Hematopoietic Stem Cell Transplantation, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Learning about the effect of excess iron in the liver of patients undergoing donor stem cell transplant may help doctors plan treatment. PURPOSE: This study is investigating the effects of iron overload in patients undergoing donor stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer, Hematopoietic Stem Cell Transplantation, Allogeneic Hematopoietic Cell Transplantation
- What is being tested?
- magnetic resonance imaging and Serum ferritin
- Type of treatment
- Surgery or procedure
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Allogeneic Hematopoietic Cell Transplantation
Who may be able to join
- Planning to undergo allogeneic hematopoietic stem cell transplantation using either myeloablative or reduced-intensity conditioning
- Any diagnosis allowed
- Not pregnant
- Weight ≤ 350 lbs
- Must be able to give written informed consent indicating the investigational nature of the study and its potential risks.
Who cannot join
- Claustrophobia
- Other contraindication for MRI (e.g., cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, insulin or infusion pump, or implanted drug infusion device)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Children's Hospital - Fairview
Minneapolis, Minnesota, 55455
About this study
Official title: Iron Overload in Allogeneic Hematopoietic Cell Transplantation
RATIONALE: Learning about the effect of excess iron in the liver of patients undergoing donor stem cell transplant may help doctors plan treatment.
PURPOSE: This study is investigating the effects of iron overload in patients undergoing donor stem cell transplant.
Read the detailed description
OBJECTIVES:
Primary
- Determine the impact of pre-transplant iron overload (defined as liver iron concentration [LIC] above normal [> 1.8 mg/g] on an MRI of the liver measuring tissue proton transverse relaxation rates [R2 MRI]) on the probability of 1-year overall survival of patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
Secondary
- Determine the impact of pre-transplant iron overload on the composite endpoint of non-relapse mortality and complications (e.g., serious infections, hepatic veno-occlusive disease, or organ failure) within 1 year after allogeneic HSCT.
- Determine the impact of pre-transplant iron overload on the 1-year cumulative incidence of acute or chronic graft-vs-host disease in patients with acute leukemia or myelodysplastic syndromes undergoing allogeneic HSCT.
- Determine the impact of pre-transplant iron overload on the 1-year probability of overall survival and non-relapse mortality in patients undergoing allogeneic HSCT.
- Determine the prevalence of pre-transplant iron overload in adult patients undergoing allogeneic HSCT.
- Determine the correlation between pre-transplant ferritin levels and LIC on R2 MRI.
- Compare the longitudinal measures of serum ferritin levels after allogeneic HSCT in patients with iron overload vs those without iron overload.
- Estimate the cumulative incidence of iron overload at 1 year after allogeneic HSCT.
OUTLINE: Patients undergo blood sample collection to measure serum ferritin levels at baseline (pre-transplant) and then at 3, 6, 9, and 12 months after transplant. Patients with serum ferritin > 500 ng/mL also undergo an R2 MRI at baseline (pre-transplant) and at 12 months after transplant to determine liver iron concentration. Patients with serum ferritin > 500 ng/mL at 12 months after transplant also undergo an R2 MRI.
- Conditions
- Cancer, Hematopoietic Stem Cell Transplantation, Allogeneic Hematopoietic Cell Transplantation
- Being tested
- magnetic resonance imaging, Serum ferritin
- Keywords
- iron overload
- Medical subject headings
- Neoplasms, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingProcedure or surgery
Also called R2 MRI
MRI of the liver will be performed within 30 days prior to HSCT (day 0) and can be done during receipt of conditioning regimen chemotherapy and/or radiation therapy. MRI will also be performed in selected patients at 1 year post-HSCT. This MRI will be done within ± 30 days of their 1-year post-transplant followup date.
The R2 MRI is a specific MRI technique and cannot be used for the purpose of general diagnostic imaging. In our study, this modality is being used specifically for the estimation of LIC.
Serum ferritinProcedure or surgery
Blood samples will be taken pre-transplant, 3, 6, 9 and 12 months post-transplant
| Study group | Role | What they receive |
|---|---|---|
| Without Iron Overload | Patients entering study without pre-HSCT iron-overload. Iron overload will be defined as liver ion concentration (LIC above normal (>1.8 mg/g) on R2 magnetic resonance imaging (MRI) of the liver. Receives: Procedure: magnetic resonance imaging; Procedure: Serum ferritin | |
| With Iron-Overload | Patients entering study with pre-HSCT iron-overload. Iron overload will be defined as liver ion concentration (LIC above normal (>1.8 mg/g) on R2 magnetic resonance imaging (MRI) of the liver. Receives: Procedure: magnetic resonance imaging; Procedure: Serum ferritin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Number of patients alive at 1 year.
Measured: 1 Year
Secondary outcomes (7)
Incidence of non-relapse mortality
Number of patients who died due to serious infections, hepatic venous occlusive disorder (VOD) or organ failure within one year of transplant.
Measured: Up to 1 Year
Acute and chronic graft-vs-host disease
Number of patients who had acute and chronic graft versus host disease through 1 year after transplant.
Measured: 1 Year Post Transplant
Overall survival and non-relapse mortality
Number of patients who were alive and did not have any non-relapse mortality events at 1 year post transplant.
Determine the impact of pre-transplant iron-overload on 1-year probability of overall survival and of non-relapse mortality in allogeneic HSCT recipients with acute leukemia and myelodysplastic syndrome.
Measured: 1 Year Post Transplant
Number of Patients with Iron Overload
Prevalence of iron overload in patients being considered for allogeneic HSCT
Measured: Baseline
Ferritin levels and Liver Iron Concentration
Correlation between pre-transplant and post-transplant ferritin levels and liver iron concentration on an MRI of the liver measuring tissue proton transverse relaxation rates (R2 MRI)
Measured: Baseline, and 3, 6, 9, and 12 Months Post Transplant
Longitudinal averages of serum ferritin levels
Compare the longitudinal measures of serum ferritin between the no iron-overload and iron-overload groups.
Measured: Post Transplant
Incidence of iron overload
Compare the longitudinal measures of serum ferritin between the no iron-overload and iron-overload groups.
Measured: 1 Year Post Transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Burns, M.D., Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888316
- Sponsor's protocol ID
- 2008NTLS103
- Other IDs
- 0807M41481, CICL670AUS28T
- Status last verified
- Nov 2017
- First submitted
- 24 Apr 2009
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Overload in Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT00888316
- Acronym / sponsor ID
- 2008NTLS103
- Conditions
- Cancer, Hematopoietic Stem Cell Transplantation, Allogeneic Hematopoietic Cell Transplantation
- Keywords
- iron overload
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Apr 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.
RATIONALE: Learning about the effect of excess iron in the liver of patients undergoing donor stem cell transplant may help doctors plan treatment.
PURPOSE: This study is investigating the effects of iron overload in patients undergoing donor stem cell transplant.
Detailed description
OBJECTIVES:
Primary
- Determine the impact of pre-transplant iron overload (defined as liver iron concentration [LIC] above normal [> 1.8 mg/g] on an MRI of the liver measuring tissue proton transverse relaxation rates [R2 MRI]) on the probability of 1-year overall survival of patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
Secondary
- Determine the impact of pre-transplant iron overload on the composite endpoint of non-relapse mortality and complications (e.g., serious infections, hepatic veno-occlusive disease, or organ failure) within 1 year after allogeneic HSCT.
- Determine the impact of pre-transplant iron overload on the 1-year cumulative incidence of acute or chronic graft-vs-host disease in patients with acute leukemia or myelodysplastic syndromes undergoing allogeneic HSCT.
- Determine the impact of pre-transplant iron overload on the 1-year probability of overall survival and non-relapse mortality in patients undergoing allogeneic HSCT.
- Determine the prevalence of pre-transplant iron overload in adult patients undergoing allogeneic HSCT.
- Determine the correlation between pre-transplant ferritin levels and LIC on R2 MRI.
- Compare the longitudinal measures of serum ferritin levels after allogeneic HSCT in patients with iron overload vs those without iron overload.
- Estimate the cumulative incidence of iron overload at 1 year after allogeneic HSCT.
OUTLINE: Patients undergo blood sample collection to measure serum ferritin levels at baseline (pre-transplant) and then at 3, 6, 9, and 12 months after transplant. Patients with serum ferritin > 500 ng/mL also undergo an R2 MRI at baseline (pre-transplant) and at 12 months after transplant to determine liver iron concentration. Patients with serum ferritin > 500 ng/mL at 12 months after transplant also undergo an R2 MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without Iron Overload | – | Procedure: magnetic resonance imaging, Procedure: Serum ferritinPatients entering study without pre-HSCT iron-overload. Iron overload will be defined as liver ion concentration (LIC above normal (>1.8 mg/g) on R2 magnetic resonance imaging (MRI) of the liver. |
| With Iron-Overload | – | Procedure: magnetic resonance imaging, Procedure: Serum ferritinPatients entering study with pre-HSCT iron-overload. Iron overload will be defined as liver ion concentration (LIC above normal (>1.8 mg/g) on R2 magnetic resonance imaging (MRI) of the liver. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Allogeneic Hematopoietic Cell Transplantation
Key inclusion criteria (5 listed)
- Planning to undergo allogeneic hematopoietic stem cell transplantation using either myeloablative or reduced-intensity conditioning
- Not pregnant
- Weight ≤ 350 lbs
- Must be able to give written informed consent indicating the investigational nature of the study and its potential risks.
Key exclusion criteria (2 listed)
- Claustrophobia
- Other contraindication for MRI (e.g., cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, insulin or infusion pump, or implanted drug infusion device)
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 |
|---|---|---|
| magnetic resonance imagingAlso: R2 MRIMRI of the liver will be performed within 30 days prior to HSCT (day 0) and can be done during receipt of conditioning regimen chemotherapy and/or radiation therapy. MRI will also be performed in selected patients at 1 year post-HSCT. This MRI will be done within ± 30 days of their 1-year post-transplant followup date. The R2 MRI is a specific MRI technique and cannot be used for the purpose of general diagnostic imaging. In our study, this modality is being used specifically for the estimation of LIC. | Procedure or surgery | With Iron-Overload, Without Iron Overload |
| Serum ferritinBlood samples will be taken pre-transplant, 3, 6, 9 and 12 months post-transplant | Procedure or surgery | With Iron-Overload, Without Iron Overload |
Primary outcome
Overall Survival
Time frame: 1 Year
Number of patients alive at 1 year.
7 secondary outcomes
Incidence of non-relapse mortality
Time frame: Up to 1 Year
Acute and chronic graft-vs-host disease
Time frame: 1 Year Post Transplant
Overall survival and non-relapse mortality
Time frame: 1 Year Post Transplant
Number of Patients with Iron Overload
Time frame: Baseline
Ferritin levels and Liver Iron Concentration
Time frame: Baseline, and 3, 6, 9, and 12 Months Post Transplant
Longitudinal averages of serum ferritin levels
Time frame: Post Transplant
Incidence of iron overload
Time frame: 1 Year Post Transplant
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 2 Dec 2017.
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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.
Linda Burns, M.D. principal investigator
Masonic Cancer Center, University of Minnesota
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 Cancer and Hematopoietic Stem Cell Transplantation, run by Masonic Cancer Center, University of Minnesota 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 5 inclusion and 2 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 2 Dec 2017. 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?
Overall Survival (time frame: 1 Year). 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 2 Dec 2017.