Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant (NCT00602446) | Clinical Trial Compass
TerminatedPhase 2
Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant
Stopped: Due to slow accrual of patients
United States4 participantsStarted 2007-08
Plain-language summary
RATIONALE: Deferasirox may be effective in treating iron overload caused by blood transfusions in patients who have undergone donor stem cell transplant.
PURPOSE: This phase II trial is studying the side effects and how well deferasirox works in treating patients with iron overload after donor stem cell transplant.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed diagnosis of iron overload, defined as serum ferritin \> 1,000 ng/mL and liver iron concentration ≥ 5 mg iron/g on tissue proton transverse relaxation rates Magnetic Resonance Imaging (MRI)
* Underwent prior allogeneic hematopoietic stem cell transplantation (HSCT) using either myeloablative or reduced-intensity conditioning at least 12 months ago
* No evidence of relapse or progression of the primary disease for which allogeneic HSCT was performed
* Patients who have become red-cell transfusion independent (i.e., no red cell transfusions within the past 3 months) as well as patients who require red cell transfusions are eligible
* Meets one of the following criteria:
* Ineligible for phlebotomy (hemoglobin \< 11 g/dL, poor intravenous access, or unable to undergo phlebotomy every 4 weeks)
* Have failed treatment with phlebotomy (serum ferritin \> 50% of baseline after 3 months of phlebotomy)
* Refused phlebotomy
* ECOG performance status of 0-2
* Life expectancy ≥ 6 months
* Adequate renal function defined as serum creatinine \< or = 1.6 mg/dL and creatinine clearance of \> or = 60 ml/min calculated using the Crockcroft-Gault formula on 2 occasions within 30 days of enrollment
* Sexually active men and women must use an effective method of contraception. Alternatively, women must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal.
* Must be able to give written informed c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients Not Completing Treatment
Timeframe: 6 Months
Trial details
NCT IDNCT00602446
SponsorMasonic Cancer Center, University of Minnesota