Oral Valganciclovir Versus Valacyclovir
Information source: M.D. Anderson Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Lymphocytic Leukemia; Leukemia
Intervention: Valganciclovir (Drug); Valacyclovir (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s):
Susan O'Brien, M.D., Principal Investigator, Affiliation: M.D. Anderson Cancer Center
Summary
To determine if the rate of cytomegalovirus reactivation during treatment with alemtuzumab
(Campath) is reduced by the use of valganciclovir prophylaxis.
Clinical Details
Official title: Open Label, Phase II Randomized Study of Oral Valganciclovir Versus Valacyclovir for Prophylaxis of Cytomegalovirus Reactivation in Patients Receiving Alemtuzumab (Campath).
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: CBC, platelet and differential. BUN, creatinine, total bilirubin, alkaline phosphatase, LDH, SGPT
Secondary outcome: CMV antigenemia
Detailed description:
Researchers will study the effectiveness of valganciclovir to help prevent cytomegalovirus
infections in patients receiving alemtuzumab. Since alemtuzumab eliminates T-cells, which
are the body's usual defense against viruses, patients taking alemtuzumab have an increased
risk of developing CMV.
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients receiving alemtuzumab
- Age > 15
- Signed informed consent form
Exclusion Criteria:
- 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.
Locations and Contacts
The University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
M.D. Anderson's Website
Starting date: September 2003
Ending date: July 2006
Last updated: December 10, 2007
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