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

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Acyclovir; Valacyclovir

Criteria

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