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

Study Overview
=================
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.

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

Conditions
-----------------
Allogeneic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Drug: Valganciclovir
* Drug: Ganciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Valganciclovir<br> | Drug: Valganciclovir<br>* Valganciclovir 450mg tablet or Valganciclovir powder for oral solution 50mg/mL<br>* Other names: Valcyte;|
| Active Comparator: Ganciclovir<br> | Drug: Ganciclovir<br>* 2x5mg/kg/d intravenous ganciclovir<br>* Other names: Cymeven;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir | 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. | max. 2 years (recruitement time) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined secondary endpoint of efficacy and safety | 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. | max. 2 years (recruitement time) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Valganciclovir, Ganciclovir, Antiviral Drug, CMV disease