Allogeneic Stem Cell Transplantation
Conditions
Keywords
Valganciclovir, Ganciclovir, Antiviral Drug, CMV disease
Brief summary
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.
Interventions
DRUGValganciclovir
Valganciclovir 450mg tablet or Valganciclovir powder for oral solution 50mg/mL
DRUGGanciclovir
2x5mg/kg/d intravenous ganciclovir
Sponsors
Roche Pharma AG
Pierrel Research Europe GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir | max. 2 years (recruitement time) | Main variable for efficacy in the primary endpoint will be evaluated by assessment of the event-free survival within 180 days after stem cell transplantation. Main variable for safety in the primary endpoint will be evaluated by the porpotion of patients with severe neutropenia until 7 days after discontinuation of antiviral therapy with the study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combined secondary endpoint of efficacy and safety | max. 2 years (recruitement time) | The secondary variables of efficacy will be: The proportion of patients with persistently positive blood specimens for CMV after completion of antiviral therapy with the Study Drug, * The proportion of patients who require retreatment after discontinuation of antiviral therapy with the Study Drug until day 180, * The proportion of patients with CMV disease within 180 days after SCT, * The number of days patients were alive and not hospitalized between randomization and day 180 post SCT, * The proportion of patients who died from any cause within 180 days after SCT. |
Countries
Austria, Germany, Spain
Outcome results
None listed