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

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ClinicalTrials.gov Identifier: NCT00330018
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : April 21, 2015
Sponsor:
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Bone Marrow Transplantation Cytomegalovirus Drug: Valganciclovir Drug: Acyclovir Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : February 2006
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
PO Valganciclovir
Drug: Valganciclovir
Valganciclovir

Active Comparator: 2
PO Acyclovir
Drug: Acyclovir
Acyclovir




Primary Outcome Measures :
  1. Prevention of CMV reactivation [ Time Frame: 100d ]

Secondary Outcome Measures :
  1. Occurrence of CMV disease [ Time Frame: 6m ]
  2. Overall survival [ Time Frame: 6m ]
  3. Occurrence of GVHD [ Time Frame: 6m ]
  4. Occurrence of other infections [ Time Frame: 6m ]


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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330018


Locations
Israel
Hadassah Medical Organization,
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Michael Y Shapira, MD Hadassah Medical Organization

Responsible Party: Michael Shapira, MD, Hadassah University Hospital
ClinicalTrials.gov Identifier: NCT00330018     History of Changes
Other Study ID Numbers: MYS-03-HMO-CTIL
First Posted: May 25, 2006    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: August 2009

Keywords provided by Hadassah Medical Organization:
BMT
CMV
GVHD

Additional relevant MeSH terms:
Valganciclovir
Ganciclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents