Trial · NCT00530218
Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant
NCT00530218, Phase 2, Completed, City of Hope Medical Center; results first posted 2017-12-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant. Trials, record NCT00530218. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00530218
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant
- NCT number
- NCT00530218
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Leukemia, Lymphoma, Multiple Myeloma, MDS, Myelodysplastic/Myeloproliferative Diseases
- Interventions
- Ganciclovir
- First posted
- 2007-09-17
- Last updated
- 2017-12-02
- Results first posted
- 2017-12-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 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. |
| Primary | Observation of Cytomegalovirus (CMV) in Blood as Measured by Either Blood Culture or Polymerase Chain Reaction (PCR) During the Course of Antiviral Treatment | Twice Weekly after day 21 post-transplant | |
| Primary | Compliance Rate Among Patients With CMV Reactivation | From first ganciclovir positive test to the end of the 6th week GCV therapy | CMV reactivation patients completed 6-week GCV therapy. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events | From first ganciclovir positive test, after day 21 post-hematopoietic cell transplant | Patients are treated with Intravenous Ganciclovir followed by Oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Observation of Cytomegalovirus (CMV) in Blood as Measured by Either Blood Culture or Polymerase Chain Reaction (PCR) During the Course of Antiviral Treatment | Twice Weekly after day 21 post-transplant | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Compliance Rate Among Patients With CMV Reactivation | From first ganciclovir positive test to the end of the 6th week GCV therapy | Among the 36 patients with CMV reactivation, two patients are in-evaluable for compliance. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group117
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | CMV Reactivation Patients With GCV | Haptoglobin | 1 | Participants | |
| Number of Participants With Adverse Events | CMV Reactivation Patients With GCV | Hemoglobin | 31 | Participants | |
| Number of Participants With Adverse Events | CMV Reactivation Patients With GCV | Hemolysis | 1 | Participants | |
| Number of Participants With Adverse Events | CMV Reactivation Patients With GCV | Leukocytes | 22 | Participants | |
| Number of Participants With Adverse Events | CMV Reactivation Patients With GCV | Lymphopenia | 2 | Participants | |
| Number of Participants With Adverse Events | CMV Reactivation Patients With GCV | Neutrophils/granulocytes | 12 | Participants | |
| Number of Participants With Adverse Events | CMV Reactivation Patients With GCV | Platelets | 26 | Participants | |
| Number of Participants With Adverse Events | CMV Reactivation Patients With GCV | pRBCs | 17 | Participants | |
| Number of Participants With Adverse Events | CMV Reactivation Patients With GCV | aGVHD | 21 | Participants | |
| Number of Participants With Adverse Events | CMV Reactivation Patients With GCV | cGVHD | 1 | Participants |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Study Participants | 61 | |
| Overall Study | COMPLETED | All Study Participants | 36 | |
| Overall Study | NOT COMPLETED | All Study Participants | 25 |
Source ClinicalTrials.gov
Adverse events226
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Haptoglobin | Blood and lymphatic system disorders | Patients With CMV Reactivation Detected | 1 | 32 | 1 |
| other | Haptoglobin | Blood and lymphatic system disorders | Patients Without CMV Reactivation Detected | 0 | 0 | 0 |
| other | Hemoglobin | Blood and lymphatic system disorders | Patients With CMV Reactivation Detected | 31 | 32 | 31 |
| other | Hemoglobin | Blood and lymphatic system disorders | Patients Without CMV Reactivation Detected | 0 | 0 | 0 |
| other | Hemolysis | Blood and lymphatic system disorders | Patients With CMV Reactivation Detected | 1 | 32 | 1 |
| other | Hemolysis | Blood and lymphatic system disorders | Patients Without CMV Reactivation Detected | 0 | 0 | 0 |
| other | Leukocytes | Blood and lymphatic system disorders | Patients With CMV Reactivation Detected | 22 | 32 | 22 |
| other | Leukocytes | Blood and lymphatic system disorders | Patients Without CMV Reactivation Detected | 0 | 0 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Patients With CMV Reactivation Detected | 2 | 32 | 2 |
| other | Lymphopenia | Blood and lymphatic system disorders | Patients Without CMV Reactivation Detected | 0 | 0 | 0 |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients With CMV Reactivation Detected | 19 | 36 |
| Total, all-cause mortality | Patients Without CMV Reactivation Detected | 14 | 25 |
| Total, other adverse events | Patients With CMV Reactivation Detected | 32 | 32 |
| Total, other adverse events | Patients Without CMV Reactivation Detected | 0 | 0 |
| Total, serious adverse events | Patients With CMV Reactivation Detected | 0 | 32 |
| Total, serious adverse events | Patients Without CMV Reactivation Detected | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Patients With CMV Reactivation Detected vs Patients Without CMV Reactivation Detected: deaths from any cause |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00530218
GET https://conductscience.org/api/trials/v1/NCT00530218/results?page=2