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

Information source: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer

Intervention: acyclovir (Drug); acyclovir sodium (Drug); valacyclovir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Fred Hutchinson Cancer Research Center

Official(s) and/or principal investigator(s):
Garrett Nichols, MD, MSC, Study Chair, Affiliation: Fred Hutchinson Cancer Research Center


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.

Clinical Details

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

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

Detailed 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.


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.



- 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)


- 12 and over

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- HIV negative

- No hypersensitivity to acyclovir or valacyclovir

- Not pregnant

- Fertile patients must use effective contraception


- See Disease Characteristics


- See Disease Characteristics

Endocrine therapy

- Not specified


- See Disease Characteristics


- Not specified

Locations and Contacts

City of Hope Comprehensive Cancer Center, Duarte, California 91010-3000, United States

Stanford Cancer Center at Stanford University Medical Center, Stanford, California 94305, United States

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska 68198-3330, United States

Baylor University Medical Center, Dallas, Texas 75246, United States

Huntsman Cancer Institute, Salt Lake City, Utah 84132, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109-1024, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2002
Last updated: September 17, 2010

Page last updated: August 23, 2015

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