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

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.

Study Overview

• Status: Terminated
• Conditions: Allogeneic Stem Cell Transplantation
• Intervention / Treatment: Drug: Valganciclovir; Drug: Ganciclovir

• Study Type: Interventional
• Enrollment (Anticipated): 212
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Pierrel Site 50
• Germany
  • Berlin, Germany
    • Pierrel Site 12
  • Berlin, Germany
    • Pierrel Site 13
  • Bremen, Germany
    • Pierrel Site 9
  • Essen, Germany
    • Pierrel Site 3
  • Kiel, Germany
    • Pierrel Site 7
  • Leipzig, Germany
    • Pierrel Site 5
  • Münster, Germany
    • Pierrel Site 4
  • Oldenburg, Germany
    • Pierrel Site 8
  • Rostock, Germany
    • Pierrel Site 10
  • Würzburg, Germany
    • Pierrel Site 1
• Spain
  • Barcelona, Spain
    • Pierrel Site 32
  • Barcelona, Spain
    • Pierrel Site33
  • Madrid, Spain
    • Pierrel Site 30
  • Madrid, Spain
    • Pierrel Site 34
  • Salamanca, Spain
    • Pierrel Site 31
  • Valencia, Spain
    • Pierrel Site 35

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Valganciclovir	Drug: Valganciclovir; Valganciclovir 450mg tablet or Valganciclovir powder for oral solution 50mg/mL; Other Names: Valcyte; Ro 107-9070
Active Comparator: Ganciclovir	Drug: Ganciclovir; 2x5mg/kg/d intravenous ganciclovir; 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)

Collaborators and Investigators

• Sponsor: Pierrel Research Europe GmbH
• Collaborators: Roche Pharma AG
• Investigators: Principal Investigator: Hermann Einsele, Prof. Dr., Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: August 18, 2010
• First Submitted That Met QC Criteria: August 18, 2010
• First Posted (Estimate): August 19, 2010

Study Record Updates

• Last Update Posted (Estimate): December 10, 2012
• Last Update Submitted That Met QC Criteria: December 7, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Ganciclovir; Antiviral Drug; Valganciclovir; CMV disease
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Valganciclovir; Ganciclovir; Ganciclovir triphosphate
• Other Study ID Numbers: ML 22371