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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

Tracking Information
First Submitted Date  ICMJE May 24, 2006
First Posted Date  ICMJE May 25, 2006
Last Update Posted Date April 21, 2015
Study Start Date  ICMJE February 2006
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2007)
Prevention of CMV reactivation [ Time Frame: 100d ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2006)
Prevention of CMV reactivation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2008)
  • Occurrence of CMV disease [ Time Frame: 6m ]
  • Overall survival [ Time Frame: 6m ]
  • Occurrence of GVHD [ Time Frame: 6m ]
  • Occurrence of other infections [ Time Frame: 6m ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2006)
  • Occurrence of CMV disease.
  • Overall survival.
  • Occurrence of GVHD.
  • Occurrence of other infections
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Bone Marrow Transplantation
  • Cytomegalovirus
Intervention  ICMJE
  • Drug: Valganciclovir
    Valganciclovir
  • Drug: Acyclovir
    Acyclovir
Study Arms  ICMJE
  • Experimental: 1
    PO Valganciclovir
    Intervention: Drug: Valganciclovir
  • Active Comparator: 2
    PO Acyclovir
    Intervention: Drug: Acyclovir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 24, 2006)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00330018
Other Study ID Numbers  ICMJE MYS-03-HMO-CTIL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Shapira, MD, Hadassah University Hospital
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Y Shapira, MD Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP