Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation

Cancer Clinical Trial

Official title:

A Phase III Multicenter Study of Cytomegalovirus Prophylaxis With Valacyclovir for the Prevention of Serious Fungal and Bacterial Infections Among Cytomegalovirus Seronegative Recipients of Cytomegalovirus Seropositive Sx Stem Cell Transplants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045292
• Other study ID #: 1603.00
• Secondary ID: FHCRC-1603.00NCI
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2002
• Last updated: September 17, 2010
• Start date: April 2002
• Est. completion date: October 2004

Study information

• Verified date: September 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Antivirals such as valacyclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valacyclovir is effective in preventing cytomegalovirus in patients undergoing stem cell transplantation.

PURPOSE: Randomized phase III trial to determine the effectiveness of valacyclovir in preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation.

Description:

OBJECTIVES:

• Compare the occurrence of serious invasive fungal or bacterial infections during the first 270 days after transplantation in cytomegalovirus (CMV)-negative patients receiving a CMV-positive allogeneic stem cell transplantation and valacyclovir or placebo.

• Compare the occurrence of primary CMV infection within the first 100 days after transplantation in patients treated with these regimens.

• Compare the survival of these patients at 100 days and 270 days post-transplantation.

• Compare the occurrence of CMV disease at day 100 and day 270 post-transplantation in patients treated with these regimens.

• Compare the safety of these regimens in these patients.

• Correlate the presence of CMV in stem cell product with post-transplantation CMV infection in these patients.

• Determine if subclinical CMV infection results in a virus-specific immune response (humoral and cellular) in these patients.

• Compare the quality of life of patients treated with these regimens.

• Compare resource utilization (e.g., rates of hospitalization, number of days alive out of the hospital, days in the intensive care unit, days on mechanical ventilation, use of antimicrobials and filgrastim [G-CSF], and number of invasive procedures) in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and type of transplantation (matched related vs mismatched/unrelated). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral valacyclovir 4 times daily beginning with transplantation conditioning (usually day -5) and continuing until day 100 after transplantation. Patients receive high-dose acyclovir, instead of valacyclovir, IV every 8 hours beginning on day -1 and continuing until oral medications are tolerated. Allogeneic stem cells are infused on day 0.

• Arm II: Patients receive oral or IV placebo on the same schedule as in arm I. Quality of life is assessed at baseline and on days 50 and 100.

Patients are followed every 2 weeks for 6 months.

PROJECTED ACCRUAL: A total of 115-230 patients (58-115 per treatment arm) will be accrued for this study within 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Disease requiring one of the following types of stem cell transplantation:

• First myeloablative allogeneic peripheral blood stem cell

• Unrelated cord blood

• Bone marrow

• Related or unrelated donor

• T-cell depleted or non-T-cell depleted

• CD34 selected or non-selected

• Patient must be cytomegalovirus (CMV)-seronegative and donor must be CMV-seropositive

• No transplantation with nonmyeloablative regimens, including any of the following:

• Fludarabine and total body irradiation (TBI) (2 Gy or less)

• TBI alone (2 Gy)

• Fludarabine, cytarabine, and idarubicin

• Fludarabine and melphalan (140 mg/m^2 or less)

• No definite or probable pre-transplantation diagnosis of invasive mold infection (aspergillosis, fusariosis, or zygomycosis), including pulmonary or hepatic nodules consistent with invasive mold infection for which patients are receiving targeted prophylaxis with amphotericin or other mold-active products

• No pre-transplantation-CMV disease (gastrointestinal or pneumonia)

PATIENT CHARACTERISTICS:

Age

• 12 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• HIV negative

• No hypersensitivity to acyclovir or valacyclovir

• Not pregnant

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

Surgery

• Not specified

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Cytomegalovirus Infections

Intervention

Drug:
• acyclovir

• acyclovir sodium

• valacyclovir

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Stanford Cancer Center at Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,