Oral Valganciclovir Versus Valacyclovir | NCT00562770

Studies
Oral Valganciclovir Versus Valacyclovir

NCT00562770

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Jul 31, 2012Estimated

Enrollment

46Actual

Phase

Phase 2

Conditions

Chronic Lymphocytic Leukemia
Leukemia

Interventions

Valganciclovir
Valacyclovir

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Not provided

Completion Date

Jul 2006Actual

First Submitted Date

Nov 20, 2007

First Submission Date that Met QC Criteria

Nov 21, 2007

First Posted Date

Nov 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2012

Last Update Posted Date

Jul 31, 2012Estimated

Name	Class
Roche Pharma AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Valacyclovir	Drug: Valacyclovir
2	Active Comparator	Valganciclovir	Drug: Valganciclovir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Valganciclovir	Drug	900 mg (two 450 mg capsules) po QD during therapy and for 2 months post alemtuzumab initiation.	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
CMV antigenemia		CMV antigenemia every 2 weeks +/- 3 days for 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan O'Brien, M.D.	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas M.D. Anderson Cancer Center		Houston	Texas	77030	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18039954	Derived	O'Brien S, Ravandi F, Riehl T, Wierda W, Huang X, Tarrand J, O'Neal B, Kantarjian H, Keating M. Valganciclovir prevents cytomegalovirus reactivation in patients receiving alemtuzumab-based therapy. Blood. 2008 Feb 15;111(4):1816-9. doi: 10.1182/blood-2007-03-080010. Epub 2007 Nov 26.

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D007938	Leukemia

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D015774	Ganciclovir
D000212	Acyclovir
D006147	Guanine
D007042	Hypoxanthines
D011688