Phase 2 Completed N=61 Supportive Care

Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant

Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable · leukemia · Lymphoma · Multiple Myeloma

Source: ClinicalTrials.gov NCT00530218 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcomePrimary: Number of Participants With Adverse Events — 1; 31; 1; 22 Participants

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.