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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).


Phase 2
16 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia, Leukemia

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CBC, platelet and differential. BUN, creatinine, total bilirubin, alkaline phosphatase, LDH, SGPT

Outcome 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.

Safety Issue:

No

Principal Investigator

Susan O'Brien, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID02-666

NCT ID:

NCT00562770

Start Date:

September 2003

Completion Date:

July 2006

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Chronic Lymphocytic Leukemia
  • CLL
  • Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

The University of Texas M.D. Anderson Cancer CenterHouston, Texas