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NCT00602446 · REGISTRY CONDITION SEARCH

Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-12-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients Not Completing Treatment

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outcome · POSTED

Reduction in Liver Iron Concentration After Study Drug

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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 consent. * Prior therapy with deferoxamine allowed provided it was completed ≥ 12 months ago Exclusion Criteria: * Contraindication for performing MRI or inability to undergo MRI because of claustrophobia or weight (\>350 pounds). * Inability to take medications orally. * Uncontrolled bacterial, viral, or fungal infection * ANC ≥ 1,000/mm³ * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 50,000/mm³ * Aspartate aminotransferance (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal * Less than 4 weeks since prior and no concurrent systemic investigational drug * Less than 7 days since prior and no concurrent topical investigational drug. Concurrent non-investigational medications needed to treat concomitant medical conditions are allowed, with the exception of other chelating agents. Concurrent growth factors such as epoetin alfa, darbepoetin alfa, filgrastim (G-CSF), and sargramostim (GM-CSF) allowed. Concurrent irradiated packed red-cell and platelet transfusions allowed as clinically indicated. Concurrent low-doses of vitamin C supplements (≤ 200 mg/day) allowed. * Concurrent iron supplements or multivitamins with iron. * Aluminum-containing antacid therapies may not be taken simultaneously with deferasirox, but may be taken 2 hours before or after administration of deferasirox * On dialysis or status post-renal transplantation * Pregnant or nursing
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Includes patients that were treated with deferasirox for 6 months.
    intervention Names
    1. Drug: deferasirox
    label
    Deferasirox Treated
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Deferasirox Treated
    description
    20 mg/kg once daily orally for 6 months
    name
    deferasirox
    other Names
    1. Exjade
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
4
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of patients who discontinued deferasirox during 6 month daily treatment due to drug related toxicity
    measure
    Number of Patients Not Completing Treatment
    time Frame
    6 Months
secondary Outcomes
  1. description
    Efficacy as measured by reduction in liver iron concentration (LIC) after 6 months of the study drug compared to baseline (LIC at baseline minus LIC at 6 months). This shows the mean reduction for the 3 subjects treated in this study.
    measure
    Reduction in Liver Iron Concentration After Study Drug
    time Frame
    6 Months
Full study description
brief 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.
detailed Description
OBJECTIVES: Primary * To evaluate the safety of deferasirox given over 6 months in reducing liver iron concentration in patients with transfusional iron overload after undergoing allogeneic hematopoietic stem cell transplantation. Secondary * To evaluate the efficacy of deferasirox in reducing liver iron overload in these patients. OUTLINE: This is a multicenter study. Patients receive oral deferasirox once daily for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed at 4 weeks.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice