Oral Valganciclovir Versus Valacyclovir

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00562770
First received: November 20, 2007
Last updated: July 27, 2012
Last verified: July 2012

November 20, 2007
July 27, 2012
September 2003
Not Provided
CBC, platelet and differential. BUN, creatinine, total bilirubin, alkaline phosphatase, LDH, SGPT [ Time Frame: 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. ] [ Designated as safety issue: No ]
CBC, platelet and differential. BUN, creatinine, total bilirubin, alkaline phosphatase, LDH, SGPT [ Time Frame: 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. ]
Complete list of historical versions of study NCT00562770 on ClinicalTrials.gov Archive Site
CMV antigenemia [ Time Frame: CMV antigenemia every 2 weeks +/- 3 days for 3 months ] [ Designated as safety issue: No ]
CMV antigenemia [ Time Frame: CMV antigenemia every 2 weeks +/- 3 days for 3 months ]
Not Provided
Not Provided
 
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).

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Drug: Valganciclovir
    900 mg (two 450 mg capsules) po QD during therapy and for 2 months post alemtuzumab initiation.
    Other Name: Valcyte
  • Drug: Valacyclovir
    500 mg po QD during therapy and for 2 months post alemtuzumab initiation.
    Other Name: Valtrex
  • Active Comparator: 1
    Valacyclovir
    Intervention: Drug: Valacyclovir
  • Active Comparator: 2
    Valganciclovir
    Intervention: Drug: Valganciclovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
July 2006
Not Provided

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00562770
ID02-666
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Roche Pharma AG
Principal Investigator: Susan O'Brien, M.D. M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP