Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-27 @ 9:53 AM
Study NCT ID:
NCT00016068
Status:
COMPLETED
Last Update Posted:
2010-05-17
First Post:
2001-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015774', 'term': 'Ganciclovir'}, {'id': 'D000077562', 'term': 'Valganciclovir'}], 'ancestors': [{'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-14', 'studyFirstSubmitDate': '2001-05-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2010-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late cytomegalovirus infection by plasma PCR positivity'}]}, 'conditionsModule': {'keywords': ['infection'], 'conditions': ['Infection']}, 'referencesModule': {'references': [{'pmid': '25560711', 'type': 'DERIVED', 'citation': 'Boeckh M, Nichols WG, Chemaly RF, Papanicolaou GA, Wingard JR, Xie H, Syrjala KL, Flowers ME, Stevens-Ayers T, Jerome KR, Leisenring W. Valganciclovir for the prevention of complications of late cytomegalovirus infection after allogeneic hematopoietic cell transplantation: a randomized trial. Ann Intern Med. 2015 Jan 6;162(1):1-10. doi: 10.7326/M13-2729.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Antivirals such as valganciclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valganciclovir is effective in preventing cytomegalovirus.\n\nPURPOSE: This randomized phase III trial is studying valganciclovir to see how well it works in preventing cytomegalovirus in patients who have undergone donor stem cell transplantation.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare cytomegalovirus (CMV) disease and non-CMV invasive infection-free survival in patients undergoing allogeneic hematopoietic stem cell transplantation treated with valganciclovir vs placebo.\n* Compare the incidence of CMV disease in patients treated with these drugs.\n* Compare the incidence of other severe invasive bacterial and fungal infections and overall survival in patients treated with these drugs.\n\nSecondary\n\n* Compare the incidence of CMV infection or disease at baseline and at days 270 and 640 after allogeneic hematopoietic stem cell transplantation in patients treated with these drugs.\n* Compare the incidence of herpes simplex virus and varicella-zoster virus infections at baseline and day 270 in patients treated with these drugs.\n* Determine the safety of valganciclovir in these patients.\n* Compare the quality of life of patients treated with these drugs.\n* Compare CMV-specific immune reconstitution in patients treated with these drugs.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, prior neutropenia (yes vs no), and presence of refractory graft-versus-host disease requiring secondary therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral valganciclovir daily.\n* Arm II: Patients receive oral placebo daily. Treatment begins around day 80-120 post-transplantation and continues until day 270 post-transplantation in the absence of active infection or unacceptable toxicity. Patients developing active cytomegalovirus (CMV) infection receive induction doses of ganciclovir IV or open-label oral valganciclovir for 1 week followed by open-label oral valganciclovir maintenance dosing until CMV can no longer be detected.\n\nQuality of life is assessed at baseline and days 180 and 270 post-transplantation.\n\nPatients are followed at days 400, 520, and 640 post-transplantation.\n\nPROJECTED ACCRUAL: A total of 184 patients (92 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Have undergone allogeneic peripheral blood stem cell, cord blood, or marrow transplantation (related or unrelated, T-cell depleted or non-T-cell depleted, CD34-selected or non-selected, or myeloablative or non-myeloablative) within the past 80-120 days\n* Positive pre-transplantation cytomegalovirus (CMV) serology of recipient and/or donor\n\n * Seropositive recipients with one of the following:\n\n * CMV infection before day 80, as determined by:\n\n * pp65 antigenemia\n * CMV DNA in plasma\n * Peripheral blood leukocytes (PBL) or whole blood at any level detected by polymerase chain reaction or hybrid capture\n * CMV pp67 mRNA\n * CMV viremia by blood culture\n * Surveillance bronchoalveolar lavage (culture or cytology)\n * CMV disease more than 6 weeks prior to enrollment\n * Presence of graft-versus-host disease (GVHD) at enrollment\n\n * Acute GVHD that requires treatment with systemic corticosteroids of doses greater than 0.5 mg/kg OR\n * Chronic clinically extensive GVHD requiring treatment with corticosteroids\n * Continuous prophylaxis with ganciclovir, foscarnet, or cidofovir between engraftment and day 80 OR\n * Seronegative recipient with seropositive donor who has CMV infection before day 80\n* No rising or uncontrolled CMV load (pp65 antigenemia levels no greater than 1/slide or no greater than 100 copies of CMV DNA per mL of plasma or per million PBL allowed)\n* No CMV disease within 6 weeks prior to randomization\n* No leukemic relapse\n\n * Cytogenetic or molecular relapse allowed\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 16 and over\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* At least 2 weeks\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,000/mm\\^3 for at least 1 week prior to enrollment\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Creatinine no greater than 2.5 mg/mL\n\nOther:\n\n* No hypersensitivity to ganciclovir or valganciclovir\n* No uncontrolled diarrhea or severe gastrointestinal disease that would preclude oral medication\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 90 days after study participation\n* HIV negative\n* Proficient in English\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* See Disease Characteristics\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* See Disease Characteristics\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* Prior ganciclovir, foscarnet, cidofovir, high-dose acyclovir, or valacyclovir as prophylaxis or preemptive therapy allowed\n* No concurrent prophylactic foscarnet, cidofovir, or ganciclovir (IV or oral)\n* No concurrent prophylactic high-dose acyclovir (more than 800 mg twice daily), valacyclovir (more than 500 mg twice daily), cidofovir (more than 0.5 mg/kg per week), or famciclovir (more than 500 mg/day) except for limited treatment courses at higher doses for varicella-zoster virus infections\n\n * Concurrent low-dose (≤ 0.5 mg/kg per week) cidofovir allowed for limited treatment courses'}, 'identificationModule': {'nctId': 'NCT00016068', 'briefTitle': 'Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'A Phase III Multicenter Study Of Valganciclovir For The Prevention Of Late Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': '1577.00'}, 'secondaryIdInfos': [{'id': 'FHCRC-1577.00'}, {'id': 'MSKCC-01127'}, {'id': 'NCI-H01-0072'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ganciclovir', 'type': 'DRUG'}, {'name': 'valganciclovir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '32610-0232', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Shands Cancer Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '48201-1379', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center at University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98109-1024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Michael Boeckh, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fred Hutchinson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}