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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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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).

Resource links provided by NLM:


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
Active Comparator: 1
Valacyclovir
Drug: Valacyclovir
500 mg po QD during therapy and for 2 months post alemtuzumab initiation.
Other Name: 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 Name: Valcyte

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Roche Pharma AG
Investigators
Principal Investigator: Susan O'Brien, M.D. M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00562770     History of Changes
Other Study ID Numbers: ID02-666
Study First Received: November 20, 2007
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
CLL
Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Acyclovir
Alemtuzumab
Ganciclovir
Valacyclovir
Valganciclovir
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014