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NCT01273766 · REGISTRY CONDITION SEARCH

Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies

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
COMPLETED
Registry last update
2018-09-07

RATIONALE: Deferasirox may remove excess iron from the body caused by blood transfusions. PURPOSE: This clinical trial studies deferasirox in treating iron overload caused by blood transfusions in patients with hematologic malignancies.

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

Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only)

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outcome · POSTED

Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics

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outcome · POSTED

Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections

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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: * Patients must have a pathology confirmed diagnosis of one of the following: myelodysplastic syndrome (MDS); acute leukemia; multiple myeloma; myelofibrosis; lymphoma; chronic anemia; sickle cell anemia * Iron score \>= 2 * Absolute Neutrophil Count (ANC) \>= 1,000 * Platelets \>= 50,000 * Albumin \>= 2 g/dL * Alkaline phosphatase =\< 5X Upper Limit of Normal (ULN) * Total bilirubin =\< 1.5 * Creatinine =\< 2X age-appropriate Upper Limit of Normal (ULN) OR creatinine clearance \>= 40 ml/min * Serum Glutamic Oxaloacetic Transaminase (SGOT) \[AST\] and Serum Glutamic Pyruvic Transaminase (SGPT) \[ALT\] =\< 5X Upper Limit of Normal (ULN) * Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1 * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients with active disease undergoing chemotherapy treatment * Patient who have been treated with rituximab or immunomodulating drugs =\< 1 month prior to enrollment * HIV-positive patients * Hepatitis-C positive patients * Women who are pregnant or breastfeeding * Patients on hemodialysis/patients with renal failure * Patients with sepsis or acute illness * Known hypersensitivity to deferasirox * Patients with moderate or severe hearing loss as defined by audiogram
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: deferasirox
    2. Other: laboratory biomarker analysis
    3. Other: enzyme-linked immunosorbent assay
    label
    Arm I
    type
    EXPERIMENTAL
  2. description
    blood tested on healthy patients
    label
    control arm
    type
    NO_INTERVENTION
  3. description
    treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
    label
    correlative
    type
    NO_INTERVENTION
interventions
  1. arm Group Labels
    1. Arm I
    description
    Given orally
    name
    deferasirox
    other Names
    1. Exjade
    2. ICL670
    type
    DRUG
  2. arm Group Labels
    1. Arm I
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
  3. arm Group Labels
    1. Arm I
    description
    Correlative studies
    name
    enzyme-linked immunosorbent assay
    other Names
    1. ELISA
    type
    OTHER
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
16
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Changes in Neutrophils between baseline and mean neutrophils values during treatment (measured after each dose)
    measure
    Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only)
    time Frame
    Baseline, up to 6 months
secondary Outcomes
  1. description
    Records will be assessed at baseline and prospectively while on study.
    measure
    Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
    time Frame
    Baseline, up to 6 months
  2. description
    Records will be assessed at baseline and prospectively while on study.
    measure
    Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections
    time Frame
    Baseline, up to 6 months
Full study description
brief Summary
RATIONALE: Deferasirox may remove excess iron from the body caused by blood transfusions. PURPOSE: This clinical trial studies deferasirox in treating iron overload caused by blood transfusions in patients with hematologic malignancies.
detailed Description
PRIMARY OBJECTIVES: I. To determine the effects of the iron-chelating agent deferasirox on changes in: neutrophil function; macrophage function; lymphocyte function. SECONDARY OBJECTIVES: I. To determine the effect of chelation on the incidence of bacterial, viral and fungal infections documented by clinical, microbiologically-proven versus radiologically-proven criteria. II. To determine the effect of iron chelation on mortality and morbidity with incidence of the following parameters: Need for hospitalization; Duration of hospitalization; Need for ventilatory support; Need for exchange transfusion/apheresis; Need for treatment with antifungals or antibiotics for documented infections. OUTLINE: Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice