Oral Valganciclovir Versus Valacyclovir
Open Label, Phase II Randomized Study of Oral Valganciclovir Versus Valacyclovir for Prophylaxis of Cytomegalovirus Reactivation in Patients Receiving Alemtuzumab (Campath).
1 other identifier
interventional
46
1 country
1
Brief Summary
To determine if the rate of cytomegalovirus reactivation during treatment with alemtuzumab (Campath) is reduced by the use of valganciclovir prophylaxis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2003
Typical duration for phase_2
1 active site
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
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 20, 2007
CompletedFirst Posted
Study publicly available on registry
November 22, 2007
CompletedJuly 31, 2012
July 1, 2012
November 20, 2007
July 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CBC, platelet and differential. BUN, creatinine, total bilirubin, alkaline phosphatase, LDH, SGPT
CBC, platelet and differential 2 weeks +/- 3 days for 8 weeks, and every 4 weeks +/- 3 days during the remainder of therapy. BUN, creatinine, total bilirubin, alkaline phosphatase, LDH, SGPT every 4 weeks +/- 3 days.
Secondary Outcomes (1)
CMV antigenemia
CMV antigenemia every 2 weeks +/- 3 days for 3 months
Study Arms (2)
1
ACTIVE COMPARATORValacyclovir
2
ACTIVE COMPARATORValganciclovir
Interventions
900 mg (two 450 mg capsules) po QD during therapy and for 2 months post alemtuzumab initiation.
500 mg po QD during therapy and for 2 months post alemtuzumab initiation.
Eligibility Criteria
You may qualify if:
- Patients receiving alemtuzumab
- Age \> 15
- Signed informed consent form
You may not qualify if:
- Active cytomegalovirus disease or infection. Asymptomatic patients with positive CMV pp65 antigenemia will not be excluded.
- Patients with a creatinine clearance of \< 10 ml/min as calculated via the Cockcroft-Gault equation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Roche Pharma AGcollaborator
Study Sites (1)
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
O'Brien S, Ravandi F, Riehl T, Wierda W, Huang X, Tarrand J, O'Neal B, Kantarjian H, Keating M. Valganciclovir prevents cytomegalovirus reactivation in patients receiving alemtuzumab-based therapy. Blood. 2008 Feb 15;111(4):1816-9. doi: 10.1182/blood-2007-03-080010. Epub 2007 Nov 26.
PMID: 18039954DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan O'Brien, M.D.
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2007
First Posted
November 22, 2007
Study Start
September 1, 2003
Study Completion
July 1, 2006
Last Updated
July 31, 2012
Record last verified: 2012-07