Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)
Information source: Hadassah Medical Organization
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bone Marrow Transplantation; Cytomegalovirus
Intervention: Valganciclovir (Drug); Acyclovir (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hadassah Medical Organization Official(s) and/or principal investigator(s): Michael Y Shapira, MD, Principal Investigator, Affiliation: Hadassah Medical Organization
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.
Clinical Details
Official title: An Investigator Initiated Prospective Randomized, Controlled Pilot Study in Order to Evaluate the Place of Valganciclovir in Prevention of Cytomegalovirus Reactivation Following Allogeneic Stem Cell Transplantation
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Prevention of CMV reactivation
Secondary outcome: Occurrence of CMV diseaseOverall survival Occurrence of GVHD Occurrence of other infections
Detailed description:
Cytomegalovirus (CMV), the most common viral infection following stem cell transplantation
(SCT), causes significant morbidity and mortality. It can result in CMV pneumonitis,
hepatitis, encephalitis and gastrointestinal disease, as well as fever and neutropenia.
Furthermore, CMV has been shown to be associated with a number of indirect effects in SCT
recipients including reduced long-term patient survival, increased risks of opportunistic
infections, allograft dysfunction, acute and chronic graft vs. host disease (GVHD). SCT
patients at highest risk are seronegative donors, matched unrelated donors, SCT with T-cell
depletion, patients after cord blood SCT, and patients with GVHD.
Valganciclovir, a valine ester pro-drug of ganciclovir, was developed to overcome the
limitations of oral and i. v. ganciclovir, with a single once-daily 900 mg oral dose
providing comparable plasma ganciclovir exposures to those achieved with 5 mg/kg i. v.
ganciclovir. Its bioavailability is up to 10-fold higher than that of oral ganciclovir (same
as above). There is already extensive clinical experience with valganciclovir in AIDS
patients, where it has proved as effective as i. v. ganciclovir in treating newly diagnosed
CMV retinitis, and in patients after solid organ transplant but no comparative data exists
in patients after SCT.
We therefore planned a prospective, randomized study to evaluate the efficacy and safety of
valganciclovir compared with acyclovir for prevention of CMV disease in SCT recipients.
Eligibility
Minimum age: 14 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Undergoing allogeneic SCT from a matched related or unrelated donor without T cell
depletion.
2. Had an acceptable engraftment.
3. Can take oral medications within 10 days of engraftment.
4. Either the recipient or donor (or both) is CMV seropositive.
Exclusion Criteria:
1. Not fulfilling the inclusion criteria.
2. History of CMV infection or disease.
3. Anti-CMV therapy within the past 15 days.
4. Severe, uncontrolled diarrhea.
5. Both recipient and donor are CMV seronegative.
6. Evidence of malabsorption.
7. Inability to comply with study requirements.
8. Known hypersensitivity or other contraindication to ganciclovir or valganciclovir.
9. Pregnant or lactating patients.
Locations and Contacts
Hadassah Medical Organization,, Jerusalem 91120, Israel
Additional Information
Starting date: February 2006
Last updated: April 19, 2015
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