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| Descriptive Information Fields | |||||
| Brief Title † | Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation | ||||
| Official Title † | A Phase III Multicenter Study Of Valganciclovir For The Prevention Of Late Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation | ||||
| Brief Summary | 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
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.
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. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Supportive Care, Randomized, Double-Blind, Placebo Control | ||||
| Primary Outcome Measure † | Late cytomegalovirus infection by plasma PCR positivity | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Cancer-Related Problem/Condition | ||||
| Intervention † | Drug: ganciclovir Drug: valganciclovir |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 184 | ||||
| Start Date † | January 2001 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00016068 | ||||
| Organization ID | CDR0000068592 | ||||
| Secondary IDs †† | FHCRC-1577.00, MSKCC-01127, NCI-H01-0072 | ||||
| Study Sponsor † | Fred Hutchinson Cancer Research Center | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | November 2006 | ||||
| First Received Date † | May 6, 2001 | ||||
| Last Updated Date | October 18, 2008 | ||||