Phase 2
N=61
Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable · Leukemia · Lymphoma · Multiple Myeloma · MDS
Bottom Line
View on ClinicalTrials.gov: NCT00530218 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Number of Participants With Adverse Events — 1; 31; 1; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ganciclovir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- City of Hope Medical Center
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
1; 31; 1; 22; 2; 12 | — |
| PRIMARY Observation of Cytomegalovirus (CMV) in Blood as Measured by Either Blood Culture or Polymerase Chain Reaction (PCR) During the Course of Antiviral Treatment |
36; 25 | — |
| PRIMARY Compliance Rate Among Patients With CMV Reactivation |
26; 8 | — |
Summary
RATIONALE: Antiviral drugs, such as ganciclovir, act against viruses. Giving ganciclovir by infusion and then by mouth may be effective treatment for cytomegalovirus that has become active after donor bone marrow transplant.
PURPOSE: This phase II trial is studying how well giving ganciclovir by infusion and by mouth works in treating patients with cytomegalovirus after donor bone marrow transplant.
Eligibility Criteria
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Undergoing allogeneic transplantation, including unrelated donor bone marrow transplantation (BMT) and/or allogeneic donor leukocyte infusion, for any indication
- Patients or their donors must have had a positive pre-BMT cytomegalovirus (CMV) antibody titer as measured by enzyme-linked immunosorbent assay (ELISA)
PATIENT CHARACTERISTICS:
- Able to comply with study requirements
Exclusion criteria
- Signs or symptoms of documented CMV infection, including any positive CMV culture from any site and/or any suspected or documented CMV-associated clinical syndrome, at the time of study entry
- History of symptomatic CMV-associated clinical syndrome
PRIOR CONCURRENT THERAPY:
- Receiving concurrent investigational antiviral agents
PATIENT CHARACTERISTICS:
- History of hypersensitivity to ganciclovir or acyclovir
Data sourced from ClinicalTrials.gov (NCT00530218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.