Oral Valganciclovir Versus Valacyclovir - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Hoffmann-La Roche
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00562770

Purpose

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

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia Leukemia	Drug: Valganciclovir Drug: Valacyclovir	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Open Label, Phase II Randomized Study of Oral Valganciclovir Versus Valacyclovir for Prophylaxis of Cytomegalovirus Reactivation in Patients Receiving Alemtuzumab (Campath).

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Valaciclovir Valacyclovir hydrochloride Campath Valganciclovir hydrochloride Valganciclovir Alemtuzumab

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

CMV antigenemia [ Time Frame: CMV antigenemia every 2 weeks +/- 3 days for 3 months ] [ Designated as safety issue: No ]

Enrollment:	46
Study Start Date:	September 2003
Study Completion Date:	July 2006

Arms	Assigned Interventions
1: Active Comparator Valacyclovir	Drug: Valacyclovir 500 mg po QD during therapy and for 2 months post alemtuzumab initiation.
2: Active Comparator Valganciclovir	Drug: Valganciclovir 900 mg (two 450 mg capsules) po QD during therapy and for 2 months post alemtuzumab initiation.

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

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562770

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Hoffmann-La Roche

Investigators

Principal Investigator:

Susan O'Brien, M.D.

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The University of Texas M. D. Anderson Cancer Center ( Susan O'Brien, M. D./Professor )
Study ID Numbers:	ID02-666
Study First Received:	November 20, 2007
Last Updated:	December 10, 2007
ClinicalTrials.gov Identifier:	NCT00562770 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Chronic Lymphocytic Leukemia
CLL
Leukemia

Additional relevant MeSH terms:

Anti-Infective Agents
Leukemia, Lymphoid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Valganciclovir
Ganciclovir
Antiviral Agents
Pharmacologic Actions

Valacyclovir
Leukemia
Lymphatic Diseases
Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Leukemia, B-Cell
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on February 08, 2010