NCT00079222

Brief Summary

RATIONALE: Antifungals, such as voriconazole and itraconazole, may be effective in preventing fungal infections in patients who are undergoing allogeneic stem cell transplantation. PURPOSE: This randomized clinical trial is studying voriconazole to see how well it works compared to itraconazole in preventing fungal infections in patients who are undergoing allogeneic hematopoietic stem cell transplantation.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Last Updated

August 3, 2020

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

March 8, 2004

Last Update Submit

July 30, 2020

Conditions

Cancer

Keywords

infectionadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionrecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiauntreated childhood acute lymphoblastic leukemiauntreated childhood acute myeloid leukemia and other myeloid malignanciesrefractory chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiaaccelerated phase chronic myelogenous leukemiaatypical chronic myeloid leukemiablastic phase chronic myelogenous leukemiachildhood chronic myelogenous leukemiachronic myelomonocytic leukemiachronic phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromesde novo myelodysplastic syndromesmyelodysplastic/myeloproliferative disease, unclassifiablepreviously treated myelodysplastic syndromeschronic eosinophilic leukemiaprimary myelofibrosischronic neutrophilic leukemiastage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory hairy cell leukemiarefractory multiple myelomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent/refractory childhood Hodgkin lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent malignant testicular germ cell tumorstage III malignant testicular germ cell tumorrecurrent ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerpoor prognosis metastatic gestational trophoblastic tumordisseminated neuroblastomarecurrent neuroblastomarecurrent ovarian germ cell tumorpreviously treated childhood rhabdomyosarcomarecurrent childhood rhabdomyosarcomarecurrent Wilms tumor and other childhood kidney tumorsstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerjuvenile myelomonocytic leukemianoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaadult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with t(15;17)(q22;q12)childhood myelodysplastic syndromes

Interventions

itraconazoleDRUG
voriconazoleDRUG

Eligibility Criteria

Age12 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Undergoing allogeneic hematopoietic stem cell transplantation * No invasive yeast infection within the past 8 weeks * Colonized or superficial infection allowed * No documented or probable aspergillus or mold infection within the past 8 weeks * Patients with a history of candidemia must have negative blood cultures and no clinical signs of candidemia PATIENT CHARACTERISTICS: Age * 12 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Fertile patients must use effective contraception * No prior allergy or intolerance to imidazoles or azoles (e.g., fluconazole, itraconazole, voriconazole, ketoconazole, miconazole, or clotrimazole) PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 1 week since prior amphotericin B or fluconazole for candidemia * No concurrent therapy with any of the following: * Rifampin * Rifabutin * Phenobarbital * Phenytoin * Carbamazepine * Oral midazolam * Triazolam * Terfenadine * Astemizole * Concurrent topical antifungal agents for superficial fungal infections allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1678, United States

Location

MeSH Terms

Conditions

NeoplasmsInfectionsPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic-PhaseMyeloproliferative DisordersPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Neutrophilic, ChronicMultiple MyelomaLeukemia, Hairy CellBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticDendritic Cell Sarcoma, InterdigitatingLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellRecurrenceMycosis FungoidesSezary SyndromeTesticular NeoplasmsCarcinoma, Ovarian EpithelialNeuroblastomaWilms TumorBreast NeoplasmsLeukemia, Myelomonocytic, JuvenileLymphoma, B-Cell, Marginal ZoneCongenital Abnormalities

Interventions

ItraconazoleVoriconazole

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveBone Marrow DiseasesMyelodysplastic-Myeloproliferative DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsLymphoma, B-CellLymphomaHistiocytic Disorders, MalignantHistiocytosisLymphoma, T-CellEndocrine Gland NeoplasmsNeoplasms by SiteGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Neoplasms, FemaleNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeoplasms, Complex and MixedKidney NeoplasmsUrologic NeoplasmsNeoplastic Syndromes, HereditaryKidney DiseasesUrologic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Mary C. Territo, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2004

First Posted

March 10, 2004

Study Start

November 1, 2003

Primary Completion

April 1, 2005

Last Updated

August 3, 2020

Record last verified: 2013-01

Locations

US(1)