Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)

NCT00330018 | Completed Phase 3 DMC

• 1 other identifier: MYS-03-HMO-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale for this protocol is based on the need to assess if the current post stem cell transplantation CMV prophylaxis strategies (e.g. high-dose acyclovir plus pre-emptive treatment) can be improved by the use of valganciclovir. CMV is the most common viral infection following stem cell transplantation, causing significant morbidity and mortality. Furthermore, CMV has been shown to be associated with a number of indirect effects in SCT recipients including allograft dysfunction, acute and chronic graft versus host disease (GVHD). Valganciclovir is shown to be more active than oral ganciclovir, and as good as intravenous (i.v.) ganciclovir in treating newly diagnosed CMV retinitis. The use of valganciclovir for CMV prophylaxis post stem cell transplantation was never tested in controlled study. The investigators therefore suggest a prospective, randomized study to evaluate the efficacy and safety of valganciclovir compared with acyclovir for prevention of CMV disease in allogeneic stem cell transplantation recipients.

Conditions

Bone Marrow Transplantation; Cytomegalovirus

Keywords

BMT; CMV; GVHD

Outcome Measures

Primary Outcomes (1)

• Prevention of CMV reactivation

  100d

Secondary Outcomes (4)

• Occurrence of CMV disease

  6m

• Overall survival

  6m

• Occurrence of GVHD

  6m

• Occurrence of other infections

  6m

Study Arms (2)

1

EXPERIMENTAL

PO Valganciclovir

Drug: Valganciclovir

2

ACTIVE COMPARATOR

PO Acyclovir

Drug: Acyclovir

Interventions

Valganciclovir DRUG

Valganciclovir

1

Acyclovir DRUG

Acyclovir

2

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing allogeneic SCT from a matched related or unrelated donor without T cell depletion.
• Had an acceptable engraftment.
• Can take oral medications within 10 days of engraftment.
• Either the recipient or donor (or both) is CMV seropositive.

You may not qualify if:

• History of CMV infection or disease.
• Anti-CMV therapy within the past 15 days.
• Severe, uncontrolled diarrhea.
• Both recipient and donor are CMV seronegative.
• Evidence of malabsorption.
• Inability to comply with study requirements.
• Known hypersensitivity or other contraindication to ganciclovir or valganciclovir.
• Pregnant or lactating patients.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization,

Jerusalem, 91120, Israel

Location

MeSH Terms

Interventions

Valganciclovir; Acyclovir

Intervention Hierarchy (Ancestors)

Ganciclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael Y Shapira, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2006
• First Posted: May 25, 2006
• Study Start: February 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 21, 2015

Record last verified: 2009-08

Locations

IL (1)