NCT00045292

Brief Summary

RATIONALE: Antivirals such as valacyclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valacyclovir is effective in preventing cytomegalovirus in patients undergoing stem cell transplantation. PURPOSE: Randomized phase III trial to determine the effectiveness of valacyclovir in preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2002

Geographic Reach
1 country

6 active sites

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

April 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

First QC Date

September 6, 2002

Last Update Submit

September 17, 2010

Conditions

Cancer

Keywords

infectionaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachildhood chronic myelogenous leukemiachronic phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemiaadult acute lymphoblastic leukemia in remissionchildhood acute lymphoblastic leukemia in remissionrecurrent adult acute lymphoblastic leukemiarecurrent childhood acute lymphoblastic leukemiauntreated adult acute lymphoblastic leukemiauntreated childhood acute lymphoblastic leukemiaadult acute myeloid leukemia in remissionchildhood acute myeloid leukemia in remissionrecurrent adult acute myeloid leukemiarecurrent childhood acute myeloid leukemiasecondary acute myeloid leukemiauntreated adult acute myeloid leukemiauntreated childhood acute myeloid leukemia and other myeloid malignanciesatypical chronic myeloid leukemiachronic eosinophilic leukemiachronic idiopathic myelofibrosischronic neutrophilic leukemiachronic myelomonocytic leukemiajuvenile myelomonocytic leukemiade novo myelodysplastic syndromesmyelodysplastic/myeloproliferative disease, unclassifiablepreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesdisseminated neuroblastomarecurrent neuroblastomanoncontiguous stage II adult diffuse large cell lymphomarecurrent adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomanoncontiguous stage II adult Burkitt lymphomarecurrent adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomanoncontiguous stage II adult diffuse mixed cell lymphomarecurrent adult diffuse mixed cell lymphomastage III adult diffuse mixed cell lymphomastage IV adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomarecurrent adult diffuse small cleaved cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomarecurrent adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomarecurrent adult lymphoblastic lymphomarecurrent childhood lymphoblastic lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomarecurrent mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomapoor prognosis metastatic gestational trophoblastic tumorpreviously treated childhood rhabdomyosarcomarecurrent Wilms tumor and other childhood kidney tumorsrecurrent adult Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomarecurrent childhood rhabdomyosarcomarecurrent childhood large cell lymphomarecurrent childhood small noncleaved cell lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent malignant testicular germ cell tumorstage III malignant testicular germ cell tumorrefractory chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory hairy cell leukemiarefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomastage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancernoncontiguous 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 lymphomachildhood myelodysplastic syndromes

Interventions

acyclovirDRUG
acyclovir sodiumDRUG
valacyclovirDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Disease requiring one of the following types of stem cell transplantation: * First myeloablative allogeneic peripheral blood stem cell * Unrelated cord blood * Bone marrow * Related or unrelated donor * T-cell depleted or non-T-cell depleted * CD34 selected or non-selected * Patient must be cytomegalovirus (CMV)-seronegative and donor must be CMV-seropositive * No transplantation with nonmyeloablative regimens, including any of the following: * Fludarabine and total body irradiation (TBI) (2 Gy or less) * TBI alone (2 Gy) * Fludarabine, cytarabine, and idarubicin * Fludarabine and melphalan (140 mg/m\^2 or less) * No definite or probable pre-transplantation diagnosis of invasive mold infection (aspergillosis, fusariosis, or zygomycosis), including pulmonary or hepatic nodules consistent with invasive mold infection for which patients are receiving targeted prophylaxis with amphotericin or other mold-active products * No pre-transplantation-CMV disease (gastrointestinal or pneumonia) PATIENT CHARACTERISTICS: Age * 12 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * HIV negative * No hypersensitivity to acyclovir or valacyclovir * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified

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

Sponsors & Collaborators

Study Sites (6)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

NeoplasmsInfectionsLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-PhasePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativePdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Neutrophilic, ChronicLeukemia, Myelomonocytic, ChronicLeukemia, Myelomonocytic, JuvenileMyeloproliferative DisordersNeuroblastomaLymphoma, Large B-Cell, DiffuseBurkitt LymphomaLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellWilms TumorHodgkin DiseaseRecurrenceDendritic Cell Sarcoma, InterdigitatingLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeCarcinoma, Ovarian EpithelialTesticular NeoplasmsLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellMultiple MyelomaBreast NeoplasmsLymphoma, B-Cell, Marginal Zone

Interventions

AcyclovirValacyclovir

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesMyelodysplastic-Myeloproliferative DiseasesNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueLymphoma, B-CellLymphomaEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsNeoplasms, Complex and MixedKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHistiocytic Disorders, MalignantHistiocytosisLymphoma, T-CellCarcinomaOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleTesticular DiseasesLeukemia, B-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Garrett Nichols, MD, MSC

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

April 1, 2002

Study Completion

October 1, 2004

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations

US(6)