Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Have undergone allogeneic peripheral blood stem cell, cord blood, or marrow transplantation (related or unrelated, T-cell depleted or non-T-cell depleted, CD34-selected or non-selected, or myeloablative or non-myeloablative) within the past 80-120 days
• •Positive pre-transplantation cytomegalovirus (CMV) serology of recipient and/or donor
• •* Seropositive recipients with one of the following:
• •* CMV infection before day 80, as determined by:
• •* pp65 antigenemia
• •* CMV DNA in plasma
• •* Peripheral blood leukocytes (PBL) or whole blood at any level detected by polymerase chain reaction or hybrid capture
• •* CMV pp67 mRNA
• •* CMV viremia by blood culture
• •* Surveillance bronchoalveolar lavage (culture or cytology)
• •* CMV disease more than 6 weeks prior to enrollment
• •* Presence of graft-versus-host disease (GVHD) at enrollment
• •* Acute GVHD that requires treatment with systemic corticosteroids of doses greater than 0.5 mg/kg OR
• •* Chronic clinically extensive GVHD requiring treatment with corticosteroids
• •* Continuous prophylaxis with ganciclovir, foscarnet, or cidofovir between engraftment and day 80 OR
• •* Seronegative recipient with seropositive donor who has CMV infection before day 80
• •No rising or uncontrolled CMV load (pp65 antigenemia levels no greater than 1/slide or no greater than 100 copies of CMV DNA per mL of plasma or per million PBL allowed)
• •No CMV disease within 6 weeks prior to randomization
• •No leukemic relapse
• •* Cytogenetic or molecular relapse allowed
• •PATIENT CHARACTERISTICS:
• •Age:
• •16 and over
• •Performance status:
• •Not specified
• •Life expectancy:
• •At least 2 weeks
• •Hematopoietic:
• •Absolute neutrophil count at least 1,000/mm\^3 for at least 1 week prior to enrollment
• •Hepatic:
• •Not specified
• •Renal:
• •Creatinine no greater than 2.5 mg/mL
• •Other:
• •No hypersensitivity to ganciclovir or valganciclovir
• •No uncontrolled diarrhea or severe gastrointestinal disease that would preclude oral medication
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 90 days after study participation
• •HIV negative
• •Proficient in English
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •See Disease Characteristics
• •Chemotherapy:
• •Not specified
• •Endocrine therapy:
• •See Disease Characteristics
• •Radiotherapy:
• •Not specified
• •Surgery:
• •Not specified
• •Other:
• •Prior ganciclovir, foscarnet, cidofovir, high-dose acyclovir, or valacyclovir as prophylaxis or preemptive therapy allowed
• •No concurrent prophylactic foscarnet, cidofovir, or ganciclovir (IV or oral)
• •No concurrent prophylactic high-dose acyclovir (more than 800 mg twice daily), valacyclovir (more than 500 mg twice daily), cidofovir (more than 0.5 mg/kg per week), or famciclovir (more than 500 mg/day) except for limited treatment courses at higher doses for varicella-zoster virus infections
• •* Concurrent low-dose (≤ 0.5 mg/kg per week) cidofovir allowed for limited treatment courses