NCT01273766|CompletedPhase 2ResultsDMCFDA Drug

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

Impact of Intervention With Deferasirox on the Immune Function of Patients With Hematologic Diseases and Transfusion-Related Iron Overload

Wake Forest University Health Sciences ClinicalTrials.gov

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3 other identifiers

IRB00015287NCI-2010-02228CCCWFU 97710

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2011

StartedJan 2011

CompletionDec 2014

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Jan 2011

Typical duration for phase_2

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.9 years study duration

Study Start

First participant enrolled

January 1, 2011

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2011

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

November 27, 2013

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed

Last Updated

September 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

January 7, 2011

Results QC Date

June 20, 2013

Last Update Submit

August 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only)
Changes in Neutrophils between baseline and mean neutrophils values during treatment (measured after each dose)
Baseline, up to 6 months

Secondary Outcomes (2)

Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
Baseline, up to 6 months
Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections
Baseline, up to 6 months

Study Arms (3)

Arm I

EXPERIMENTAL

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.

Drug: deferasiroxOther: laboratory biomarker analysisOther: enzyme-linked immunosorbent assay

control arm

NO INTERVENTION

blood tested on healthy patients

correlative

NO INTERVENTION

treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis

Interventions

deferasiroxDRUG

Given orally

Also known as: Exjade, ICL670

Arm I

laboratory biomarker analysisOTHER

Correlative studies

Arm I

enzyme-linked immunosorbent assayOTHER

Correlative studies

Also known as: ELISA

Arm I

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Wake Forest University Health Scienceslead
National Cancer Institute (NCI)collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Leukemia, Biphenotypic, AcuteCongenital AbnormalitiesHistiocytosis, Langerhans-CellLymphoma, Extranodal NK-T-CellLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyIntraocular LymphomaLeukemia, Mast-CellChromosome 5q Deletion SyndromeMyeloproliferative DisordersLymphoma, B-Cell, Marginal ZoneLymphoma, T-Cell, PeripheralPrimary MyelofibrosisPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellAnemia, RefractoryMultiple MyelomaWaldenstrom Macroglobulinemia

Interventions

DeferasiroxEnzyme-Linked Immunosorbent Assay

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesHistiocytosisLymphoma, T-CellLymphomaLymphadenopathyEye NeoplasmsNeoplasms by SiteLeukemia, MyeloidMastocytosis, SystemicMastocytosisMast Cell Activation DisordersBone Marrow DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemiaMyelodysplastic SyndromesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

BenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImmunoenzyme TechniquesImmunoassayImmunologic TechniquesInvestigative TechniquesImmunosorbent TechniquesImmunohistochemistryMolecular Probe Techniques

Limitations and Caveats

adverse events were only tracked on Arm I

Results Point of Contact

Title: Dr. Mary Ann Knovich
Organization: Comprehensive Cancer Center of Wake Forest University

Study Officials

Mary Ann Knovich, MD
Wake Forest University Health Sciences
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 7, 2011

First Posted

January 10, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2012

Study Completion

December 1, 2014

Last Updated

September 7, 2018

Results First Posted

November 27, 2013

Record last verified: 2018-08

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Results Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (3)

Arm I

control arm

correlative

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations