Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation

Multicenter, Randomized Study Comparing Oral Valganciclovir Versus Intravenous Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation

The objective of this study is to assess the efficacy and safety of oral valganciclovir versus intravenous ganciclovir in patients following allogenic stem cell transplantation.

Inclusion Criteria:

• Patient following allogeneic SCT
• Patient with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after SCT
• Absolute neutrophil count (ANC) ≥1000 cells/µL on 2 consecutive follow-ups within 10 days before randomization
• Patient has a creatinine clearance of ≥25 mL/min (calculated by the Cockcroft-Gault formula, see Part I Section 6.1.2) with evidence of improving renal function,
• None or gastrointestinal graft-versus-host disease (GVHD) up to grade 2

Exclusion Criteria:

• Patient has a suspected or diagnosed CMV disease

• Patient has received syngeneic SCT

• Patient who received an investigational medicinal product (IMP) within the last 30 days prior to screening or who is simultaneously participating in another clinical study with an IMP

• Patient with a body weight <50 kg or >95 kg,

• Patient has received anti-CMV therapy within the past 30 days prior to screening (the use of acyclovir, valacyclovir, or famciclovir is permitted)

• Patient who has participated in this study before,

• Patient who shows a neutropenia, thrombocytopenia, or anemia within 10 days before or at the time point of randomization as following:

  • The ANC is <1000 cells/μL on 2 consecutive follow-ups, or
  • A platelet count of ≥25000/μL can not be achieved/maintained with platelet transfusions
  • A hemoglobin level of ≥8g/dL can not be achieved/maintained by red blood cell transfusions