Trial · NCT00578643
Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease
NCT00578643, Phase 2, Completed, Baylor College of Medicine; results first posted 2018-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease. Trials, record NCT00578643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00578643
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease
- NCT number
- NCT00578643
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Chronic Granulomatous Disease
- Interventions
- Busulfan, Alemtuzumab, Cyclophosphamide, Fludarabine, Cyclosporine, Stem Cell Infusion
- First posted
- 2007-12-21
- Last updated
- 2018-11-09
- Results first posted
- 2018-11-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Engraftment | 28 days post transplant | To estimate the engraftment rate for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors. |
| Secondary | Number of Patients That Have Complete Donor Chimerism After Transplant. | 120 days post transplant | To estimate the likelihood of complete donor chimerism for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors. |
| Secondary | Number of Patients That Have Acute GVHD and Regimen Related Morbidity/Mortality Post Transplant. | Assessed between day 0 and day 100 post transplant | To estimate the risk for acute GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors. |
| Secondary | Number of Patients That Have Chronic GVHD and Regimen Related Morbidity/Mortality Post Transplant. | Assessed between day 100 and day 365 post transplant | To estimate the risk for chronic GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Engraftment | 28 days post transplant | percentage of participants | NUMBER | |
| SECONDARY | Number of Patients That Have Complete Donor Chimerism After Transplant. | 120 days post transplant | One patient died on day 62 post transplant and was not included in the analysis. | participants | NUMBER |
| SECONDARY | Number of Patients That Have Acute GVHD and Regimen Related Morbidity/Mortality Post Transplant. | Assessed between day 0 and day 100 post transplant | One patient who died on day 62 post transplant without developing acute GVHD was not assessed for this Outcome Measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients That Have Chronic GVHD and Regimen Related Morbidity/Mortality Post Transplant. | Assessed between day 100 and day 365 post transplant | One patient died on day 62 post transplant, and one patient was lost to F/U on day 163 post transplant. They were not assessed for this Outcome Measure. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Engraftment | Allogeneic Unrelated Transplant | 100 | percentage of participants | ||
| Number of Patients That Have Complete Donor Chimerism After Transplant. | Allogeneic Unrelated Transplant | 13 | participants | ||
| Number of Patients That Have Acute GVHD and Regimen Related Morbidity/Mortality Post Transplant. | Allogeneic Unrelated Transplant | None | 8 | Participants | |
| Number of Patients That Have Acute GVHD and Regimen Related Morbidity/Mortality Post Transplant. | Allogeneic Unrelated Transplant | Grade I | 6 | Participants | |
| Number of Patients That Have Acute GVHD and Regimen Related Morbidity/Mortality Post Transplant. | Allogeneic Unrelated Transplant | Grade II | 0 | Participants | |
| Number of Patients That Have Acute GVHD and Regimen Related Morbidity/Mortality Post Transplant. | Allogeneic Unrelated Transplant | Grade III-IV | 0 | Participants | |
| Number of Patients That Have Chronic GVHD and Regimen Related Morbidity/Mortality Post Transplant. | Allogeneic Unrelated Transplant | Yes | 0 | Participants | |
| Number of Patients That Have Chronic GVHD and Regimen Related Morbidity/Mortality Post Transplant. | Allogeneic Unrelated Transplant | No | 13 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Allogeneic Unrelated Transplant | 15 | |
| Overall Study | COMPLETED | Allogeneic Unrelated Transplant | 13 | |
| Overall Study | NOT COMPLETED | Allogeneic Unrelated Transplant | 2 |
Source ClinicalTrials.gov
Adverse events41
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 | Hypertension | Cardiac disorders | Allogeneic Unrelated Transplant | 3 | 15 | 3 |
| other | Dehydration | Gastrointestinal disorders | Allogeneic Unrelated Transplant | 1 | 15 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Allogeneic Unrelated Transplant | 1 | 15 | 1 |
| other | Diarrhea patients without colostomy | Gastrointestinal disorders | Allogeneic Unrelated Transplant | 1 | 15 | 3 |
| other | Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | Allogeneic Unrelated Transplant | 1 | 15 | 1 |
| other | Hematuria (in the absence of vaginal bleeding) | Infections and infestations | Allogeneic Unrelated Transplant | 1 | 15 | 1 |
| other | GGT (Gamma-Glutamyl transpeptidase) | Hepatobiliary disorders | Allogeneic Unrelated Transplant | 2 | 15 | 3 |
| other | SGOT (AST) (serum glutamic oxaloacetic transaminase) | Hepatobiliary disorders | Allogeneic Unrelated Transplant | 2 | 15 | 2 |
| other | SGPT (ALT) (serum glutamic pyruvic transaminase) | Hepatobiliary disorders | Allogeneic Unrelated Transplant | 1 | 15 | 1 |
| other | Catheter-related infection | Infections and infestations | Allogeneic Unrelated Transplant | 1 | 15 | 1 |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Allogeneic Unrelated Transplant | 1 | 15 |
| Total, other adverse events | Allogeneic Unrelated Transplant | 14 | 15 |
| Total, serious adverse events | Allogeneic Unrelated Transplant | 9 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00578643
GET https://conductscience.org/api/trials/v1/NCT00578643/events?page=2