Oral Valganciclovir Versus Valacyclovir

Study Overview
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Brief Summary
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To determine if the rate of cytomegalovirus reactivation during treatment with alemtuzumab (Campath) is reduced by the use of valganciclovir prophylaxis.

Detailed Description
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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.

Official Title
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Open Label, Phase II Randomized Study of Oral Valganciclovir Versus Valacyclovir for Prophylaxis of Cytomegalovirus Reactivation in Patients Receiving Alemtuzumab (Campath).

Conditions
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Chronic Lymphocytic Leukemia, Leukemia

Intervention / Treatment
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* Drug: Valganciclovir
* Drug: Valacyclovir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Valacyclovir | Drug: Valacyclovir<br>* 500 mg po QD during therapy and for 2 months post alemtuzumab initiation.<br>* Other names: Valtrex;|
| Active Comparator: 2<br>Valganciclovir | Drug: Valganciclovir<br>* 900 mg (two 450 mg capsules) po QD during therapy and for 2 months post alemtuzumab initiation.<br>* Other names: Valcyte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMV antigenemia |  | CMV antigenemia every 2 weeks +/- 3 days for 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLL, Chronic Lymphocytic Leukemia, Leukemia