Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2003-09-30
2006-07-31
Brief Summary
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Detailed Description
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Before treatment, you will have a physical exam. You will also have around 3-4 tablespoons of blood drawn for routine tests and for tests to see if you have ever been exposed to CMV.
You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will be given treatment with valganciclovir. Participants in the other group will be given treatment with valacyclovir. This drug protects against herpes infections but not CMV.
If you are assigned to the group that will receive valganciclovir, you will take valganciclovir by mouth once a day starting of your first day of alemtuzumab therapy. You will continue to take valganciclovir for 2 months after the end of alemtuzumab therapy.
If you are assigned to the group that will receive valacyclovir, you will take valacyclovir by mouth once a day starting of your first day of alemtuzumab therapy. You will continue to take valacyclovir for 2 months after the end of alemtuzumab therapy.
Every 2 weeks while you are receiving alemtuzumab (usually 4-12 weeks)you will have a repeat blood test to look for CMV.
Your participation in this study will last for a maximum of 5 months.
This is an investigational study. Both valganciclovir and valacyclovir are FDA approved and commercially available. However, the use of valganciclovir for this study is experimental. valganciclovir will be provided free of charge during the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Valacyclovir
Valacyclovir
500 mg po QD during therapy and for 2 months post alemtuzumab initiation.
2
Valganciclovir
Valganciclovir
900 mg (two 450 mg capsules) po QD during therapy and for 2 months post alemtuzumab initiation.
Interventions
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Valganciclovir
900 mg (two 450 mg capsules) po QD during therapy and for 2 months post alemtuzumab initiation.
Valacyclovir
500 mg po QD during therapy and for 2 months post alemtuzumab initiation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 15
* Signed informed consent form
Exclusion Criteria
* Patients with a creatinine clearance of \< 10 ml/min as calculated via the Cockcroft-Gault equation.
16 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Susan O'Brien, M.D.
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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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.
Related Links
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M.D. Anderson's Website
Other Identifiers
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ID02-666
Identifier Type: -
Identifier Source: org_study_id