- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00016068
Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation
A Phase III Multicenter Study Of Valganciclovir For The Prevention Of Late Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
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.
PURPOSE: 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Compare cytomegalovirus (CMV) disease and non-CMV invasive infection-free survival in patients undergoing allogeneic hematopoietic stem cell transplantation treated with valganciclovir vs placebo.
- Compare the incidence of CMV disease in patients treated with these drugs.
- Compare the incidence of other severe invasive bacterial and fungal infections and overall survival in patients treated with these drugs.
Secondary
- 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.
- Compare the incidence of herpes simplex virus and varicella-zoster virus infections at baseline and day 270 in patients treated with these drugs.
- Determine the safety of valganciclovir in these patients.
- Compare the quality of life of patients treated with these drugs.
- Compare CMV-specific immune reconstitution in patients treated with these drugs.
OUTLINE: 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.
- Arm I: Patients receive oral valganciclovir daily.
- 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.
Quality of life is assessed at baseline and days 180 and 270 post-transplantation.
Patients are followed at days 400, 520, and 640 post-transplantation.
PROJECTED ACCRUAL: A total of 184 patients (92 per treatment arm) will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010-3000
- City of Hope Comprehensive Cancer Center
-
-
Florida
-
Gainesville, Florida, United States, 32610-0232
- University of Florida Shands Cancer Center
-
-
Michigan
-
Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Texas
-
Houston, Texas, United States, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
-
-
Washington
-
Seattle, Washington, United States, 98109-1024
- Fred Hutchinson Cancer Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- 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
Positive pre-transplantation cytomegalovirus (CMV) serology of recipient and/or donor
Seropositive recipients with one of the following:
CMV infection before day 80, as determined by:
- pp65 antigenemia
- CMV DNA in plasma
- Peripheral blood leukocytes (PBL) or whole blood at any level detected by polymerase chain reaction or hybrid capture
- CMV pp67 mRNA
- CMV viremia by blood culture
- Surveillance bronchoalveolar lavage (culture or cytology)
- CMV disease more than 6 weeks prior to enrollment
Presence of graft-versus-host disease (GVHD) at enrollment
- Acute GVHD that requires treatment with systemic corticosteroids of doses greater than 0.5 mg/kg OR
- Chronic clinically extensive GVHD requiring treatment with corticosteroids
- Continuous prophylaxis with ganciclovir, foscarnet, or cidofovir between engraftment and day 80 OR
- Seronegative recipient with seropositive donor who has CMV infection before day 80
- 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)
- No CMV disease within 6 weeks prior to randomization
No leukemic relapse
- Cytogenetic or molecular relapse allowed
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- Not specified
Life expectancy:
- At least 2 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm^3 for at least 1 week prior to enrollment
Hepatic:
- Not specified
Renal:
- Creatinine no greater than 2.5 mg/mL
Other:
- No hypersensitivity to ganciclovir or valganciclovir
- No uncontrolled diarrhea or severe gastrointestinal disease that would preclude oral medication
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 90 days after study participation
- HIV negative
- Proficient in English
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- Not specified
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- Prior ganciclovir, foscarnet, cidofovir, high-dose acyclovir, or valacyclovir as prophylaxis or preemptive therapy allowed
- No concurrent prophylactic foscarnet, cidofovir, or ganciclovir (IV or oral)
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
- Concurrent low-dose (≤ 0.5 mg/kg per week) cidofovir allowed for limited treatment courses
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Late cytomegalovirus infection by plasma PCR positivity
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Michael Boeckh, MD, Fred Hutchinson Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Virus Diseases
- Disease Attributes
- DNA Virus Infections
- Herpesviridae Infections
- Infections
- Communicable Diseases
- Cytomegalovirus Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Valganciclovir
- Ganciclovir
- Ganciclovir triphosphate
Other Study ID Numbers
- 1577.00
- FHCRC-1577.00
- MSKCC-01127
- NCI-H01-0072
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infection
-
West Virginia UniversityEnrolling by invitationSkin and Soft Tissue Infection | Gastrointestinal Infection | Pulmonary Infection | Bone and Joint Infection | Endovascular Infection | Genitourinary InfectionUnited States
-
Ondine Biomedical Inc.CompletedSurgical Site Infection | Nosocomial Infection | Healthcare Associated InfectionUnited States
-
Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemCompletedSurgical Site Infection | Superficial Surgical Site Infection | Deep Surgical Site Infection | Organ/Space Surgical Site InfectionUnited States
-
Croydon Health Services NHS TrustCompletedSurgical Site Infection | Wound Infection | Cesarean Section; Infection | Perineal InfectionUnited Kingdom
-
Cairo UniversityRecruitingPostoperative Infection | Cesarean Section Complications | Vaginal InfectionEgypt
-
Leiden University Medical CenterRadboud University Medical Center; University Medical Center Groningen; Erasmus... and other collaboratorsRecruitingProsthetic-joint Infection | Infection Hip | Infection; Knee, JointNetherlands
-
University of ZurichCompletedProsthetic Joint Infection | Surgical Site Infection | Prosthesis and Implants | Postoperative Wound Infection Deep Incisional Surgical SiteSwitzerland
-
University of ZurichCompletedProsthetic Joint Infection | Surgical Site Infection | Prosthesis and Implants | Postoperative Wound Infection Deep Incisional Surgical SiteSwitzerland
-
Vastra Gotaland RegionGöteborg UniversityRecruitingProsthetic Joint Infection | Hip Prosthesis Infection | Prosthetic Infection | Knee Prosthesis InfectionSweden
-
Duke UniversityAgency for Healthcare Research and Quality (AHRQ)CompletedSurgical Site Infection | Infection ControlUnited States
Clinical Trials on valganciclovir
-
Luis Eduardo Morales BuenrostroCompletedKidney Transplantation | Pharmacokinetics | Cytomegalovirus Infections | Therapeutic EquivalencyMexico
-
Stanford UniversityCompleted
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); Weill Medical College of Cornell University; University of North Carolina, Chapel Hill and other collaboratorsCompletedSarcomaUnited States
-
Rabin Medical CenterCompletedInfection in Solid Organ Transplant RecipientsIsrael
-
University of California, San FranciscoRoche Pharma AGCompletedHIV Infections | Cytomegalovirus InfectionsUnited States
-
Hoffmann-La RocheCompletedCytomegalovirus InfectionsUnited States
-
Dr. Reddy's Laboratories LimitedCompleted
-
Dr. Reddy's Laboratories LimitedCompleted
-
Scott PalmerRoche Pharma AGCompletedCytomegalovirus InfectionsUnited States
-
Karolinska InstitutetKarolinska University HospitalCompletedGlioblastoma Multiforme | Cytomegalovirus InfectionSweden