Oral Valganciclovir Versus Valacyclovir

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00562770

Collaborator

Roche Pharma AG (Industry)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia Leukemia	Drug: Valganciclovir Drug: Valacyclovir	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2003

Actual Study Completion Date :

Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Valacyclovir	Drug: Valacyclovir 500 mg po QD during therapy and for 2 months post alemtuzumab initiation. Other Names: Valtrex
Active Comparator: 2 Valganciclovir	Drug: Valganciclovir 900 mg (two 450 mg capsules) po QD during therapy and for 2 months post alemtuzumab initiation. Other Names: Valcyte

Arm

Intervention/Treatment

Active Comparator: 1

Valacyclovir

Drug: Valacyclovir

500 mg po QD during therapy and for 2 months post alemtuzumab initiation.

Other Names:

Valtrex

Active Comparator: 2

Valganciclovir

Drug: Valganciclovir

900 mg (two 450 mg capsules) po QD during therapy and for 2 months post alemtuzumab initiation.

Other Names:

Valcyte

Outcome Measures

Primary Outcome Measures

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

CMV antigenemia [CMV antigenemia every 2 weeks +/- 3 days for 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.