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 range18 Years – 70 Years
SexALL
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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…
What they're measuring
1
Number of Patients Not Completing Treatment
Timeframe: 6 Months
Trial details
NCT IDNCT00602446
SponsorMasonic Cancer Center, University of Minnesota