Back to resultsGanciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant
Primary Purpose
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Leukemia, Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ganciclovir
Sponsored by
About this trial
This is an interventional supportive care trial for Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
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
Sites / Locations
- City of Hope National Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All Study Participants
Arm Description
Ganciclovir IV 5 mg/kg/bid x 7 days followed by Ganciclovir Oral 1000 mg tid 7 days per week x 5 weeks
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
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
Compliance Rate Among Patients With CMV Reactivation
CMV reactivation patients completed 6-week GCV therapy.
Secondary Outcome Measures
Full Information
NCT ID
NCT00530218
First Posted
September 13, 2007
Last Updated
October 25, 2017
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00530218
Brief Title
Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant
Official Title
Phase II Study of Intravenous Ganciclovir Followed by Oral Ganciclovir in the Treatment of Reactivation of CMV Following Bone Marrow Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
OBJECTIVES:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Leukemia, Lymphoma, Multiple Myeloma, MDS, Myelodysplastic/Myeloproliferative Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All Study Participants
Arm Type
Experimental
Arm Description
Ganciclovir IV 5 mg/kg/bid x 7 days followed by Ganciclovir Oral 1000 mg tid 7 days per week x 5 weeks
Intervention Type
Drug
Intervention Name(s)
Ganciclovir
Other Intervention Name(s)
Cytovene
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
This will be measured by the number of the CMV+ participants with adverse events occurring when receiving oral GCV.
Time Frame
From first ganciclovir positive test, after day 21 post-hematopoietic cell transplant
Title
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
Title
Compliance Rate Among Patients With CMV Reactivation
Description
CMV reactivation patients completed 6-week GCV therapy.
Time Frame
From first ganciclovir positive test to the end of the 6th week GCV therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo T. Spielberger, MD
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
R. Spielberger, J. Zaia, R. A. Nelson, E. Newman, G. Gallez-Hawkins, A. Ahlers, J. Stevenson, C. Acedo, A. Alam, R. Bhatia, S. Cohen, P. Falk, H. Fung, A.Kashyap, N. Kogut, Al Krishnan, A. Molina, A. Nademanee, M. O'Donnell, P. Parker, L. Popplewell, R. Rodriguez, F. Sahebi, D. Snyder, A. Stein, S. Forman. Use of Oral Ganciclovir (PO-GCV) for the Preemptive Treatment (Tx) of CMV Following Allogeneic HCT: Safety and Feasibility Results. Blood 96 (11): 586A # 2516, 2000.
Results Reference
background
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Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant
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