Randomized study of oral ganciclovir versus i.v. ganciclovir for preemptive therapy of cytomegalovirus infection after stem cell transplantation.

Conditions: First cytomegalovirus DNAemia after stem cell transplantation
MedDRA version: 12.1Level: LLTClassification code 10063310Term: Cytomegalovirus DNA test positive

Registration Number: EUCTR2010-020551-31-FI

Lead Sponsor: ordic Bone and Marrow Transplantation Group

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 168

Inclusion Criteria

Allogeneic SCT recipients > 50 kg of body weight, adults and children > 12 years of age
Donor: sibling or an unrelated donor
Conditioning: myeloablative and reduced intensity
First CMV DNAemia after SCT
Patients give their informed consent.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

B-neutrophils < 1x109/L.
Patient unable to take oral medication
Acute intestinal GVHD or ongoing grade III-IV liver GVHD
Patients with leukaemia in relapse

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to demonstrate that the treatment result with oral valganciclovir is not inferior to that obtained with iv ganciclovir in the tretament of CMV DNAemia after stem cell transplantation;Secondary Objective: As secondary endpoints CMV disease, cytopenias, acute graft-versus-host disease, atransplant related mortality, and death of any cause are analyzed.;Primary end point(s): Achievement of CMV PCR negativity during preemptive treatment of the first CMV DNAemia of the SCT recipients on day 28 or earlier in the two treatment arms.

Secondary Outcome Measures