Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant
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|ClinicalTrials.gov Identifier: NCT00530218|
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : December 2, 2017
Last Update Posted : December 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Leukemia Lymphoma Multiple Myeloma MDS Myelodysplastic/Myeloproliferative Diseases||Drug: Ganciclovir||Phase 2|
- To determine the feasibility of using oral ganciclovir (GCV) following induction with intravenous GCV in the setting of cytomegalovirus (CMV) reactivation after bone marrow transplantation.
OUTLINE: Blood cultures for cytomegalovirus (CMV) are obtained periodically after the planned bone marrow transplantation (BMT). Patients showing reactivation of CMV receive induction ganciclovir (GCV) IV twice a day on days 1-7. Patients then receive maintenance oral GCV three times a day for 5 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically during study for pharmacokinetic studies.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase II Study of Intravenous Ganciclovir Followed by Oral Ganciclovir in the Treatment of Reactivation of CMV Following Bone Marrow Transplant|
|Study Start Date :||March 1999|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Experimental: All Study Participants
Ganciclovir IV 5 mg/kg/bid x 7 days followed by Ganciclovir Oral 1000 mg tid 7 days per week x 5 weeks
Following the first CMV-positive blood culture on day 21 or later, or the first two consecutive CMV-positive PCR tests on day 21 or later, 5mg/kg/bid x 7 days of Ganciclovir is given intravenously, followed by oral Ganciclovir 1000 mg tid 7 days per week x 5 weeks
Other Name: Cytovene
- Number of Participants With Adverse Events [ Time Frame: From first ganciclovir positive test, after day 21 post-hematopoietic cell transplant ]This will be measured by the number of the CMV+ participants with adverse events occurring when receiving oral GCV.
- Observation of Cytomegalovirus (CMV) in Blood as Measured by Either Blood Culture or Polymerase Chain Reaction (PCR) During the Course of Antiviral Treatment [ Time Frame: Twice Weekly after day 21 post-transplant ]
- Compliance Rate Among Patients With CMV Reactivation [ Time Frame: From first ganciclovir positive test to the end of the 6th week GCV therapy ]CMV reactivation patients completed 6-week GCV therapy.
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): NCT00530218
|United States, California|
|City of Hope National Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Ricardo T. Spielberger, MD||City of Hope Comprehensive Cancer Center|