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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Antivirals such as valganciclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valganciclovir is effective in preventing cytomegalovirus.

PURPOSE: This randomized phase III trial is studying valganciclovir to see how well it works in preventing cytomegalovirus in patients who have undergone 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: Ganciclovir; Ganciclovir triphosphate; Valganciclovir

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