Trial · NCT00258427
Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia
NCT00258427, Phase 2, Completed, Masonic Cancer Center, University of Minnesota; results first posted 2021-12-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia. Trials, record NCT00258427. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00258427
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia
- NCT number
- NCT00258427
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Fanconi Anemia
- Interventions
- anti-thymocyte globulin, filgrastim, busulfan, cyclophosphamide, fludarabine phosphate, methylprednisolone, Hematopoietic stem cell transplantation
- First posted
- 2005-11-24
- Last updated
- 2021-12-02
- Results first posted
- 2021-12-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Graft Failure | Day 30 | Graft failure is defined as absolute neutrophil count( ANC ) \<5 x 10\^8/L by day 30. |
| Secondary | Number of Participants Experiencing Chronic Graft-Versus-Host Disease | Day 42 | Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cellsinto a foreign host. |
| Secondary | Number of Participants Experiencing Chronic Graft-Versus-Host Disease | 1 year | Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cellsinto a foreign host. |
| Secondary | Number of Participants Experiencing Acute Graft-Versus-Host Disease | 1 year | Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. |
| Secondary | Number of Participants Experiencing Acute Graft-Versus-Host Disease | Day 42 | Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. |
| Secondary | Number of Participants Experiencing Relapse | 1 Year | Patients with leukemia will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. |
| Secondary | Number of Participants Experiencing Overall Survival | 1 Year | Overall Survival - Number of patients alive at 1 year post transplant |
| Secondary | Number of Participants Experiencing Major Infections | Day 1 through 1 year post-transplant | Number of participants experiencing Major Infections by the end of treatment |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Graft Failure | Day 30 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Chronic Graft-Versus-Host Disease | Day 42 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Chronic Graft-Versus-Host Disease | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Acute Graft-Versus-Host Disease | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Acute Graft-Versus-Host Disease | Day 42 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Relapse | 1 Year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Overall Survival | 1 Year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Major Infections | Day 1 through 1 year post-transplant | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing Graft Failure | Marrow Isolex | 1 | Participants | ||
| Number of Participants Experiencing Graft Failure | USB Arm | 0 | Participants | ||
| Number of Participants Experiencing Graft Failure | Marrow Clinimacs | 0 | Participants | ||
| Number of Participants Experiencing Graft Failure | Sibling withoutCliniMACS | 0 | Participants | ||
| Number of Participants Experiencing Chronic Graft-Versus-Host Disease | Marrow Isolex | 0 | Participants | ||
| Number of Participants Experiencing Chronic Graft-Versus-Host Disease | USB Arm | 0 | Participants | ||
| Number of Participants Experiencing Chronic Graft-Versus-Host Disease | Marrow Clinimacs | 0 | Participants | ||
| Number of Participants Experiencing Chronic Graft-Versus-Host Disease | Sibling withoutCliniMACS | 0 | Participants | ||
| Number of Participants Experiencing Chronic Graft-Versus-Host Disease | Marrow Isolex | 0 | Participants | ||
| Number of Participants Experiencing Chronic Graft-Versus-Host Disease | USB Arm | 0 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Marrow Isolex | 3 | |
| Overall Study | STARTED | USB Arm | 8 | |
| Overall Study | STARTED | Marrow Clinimacs | 2 | |
| Overall Study | STARTED | Sibling withoutCliniMACS | 1 | |
| Overall Study | COMPLETED | Marrow Isolex | 3 | |
| Overall Study | COMPLETED | USB Arm | 8 | |
| Overall Study | COMPLETED | Marrow Clinimacs | 2 | |
| Overall Study | COMPLETED | Sibling withoutCliniMACS | 1 | |
| Overall Study | NOT COMPLETED | Marrow Isolex | 0 | |
| Overall Study | NOT COMPLETED | USB Arm | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events124
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 | Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | Marrow Isolex | 0 | 3 | 0 |
| other | Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | USB Arm | 1 | 8 | 1 |
| other | Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | Marrow Clinimacs | 0 | 2 | 0 |
| other | Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | Sibling withoutCliniMACS | 0 | 1 | 0 |
| other | Acute kidney injury | Renal and urinary disorders | Marrow Isolex | 0 | 3 | 0 |
| other | Acute kidney injury | Renal and urinary disorders | USB Arm | 2 | 8 | 2 |
| other | Acute kidney injury | Renal and urinary disorders | Marrow Clinimacs | 0 | 2 | 0 |
| other | Acute kidney injury | Renal and urinary disorders | Sibling withoutCliniMACS | 0 | 1 | 0 |
| other | acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Marrow Isolex | 1 | 3 | 1 |
| other | acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | USB Arm | 0 | 8 | 0 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Marrow Isolex | 2 | 3 |
| Total, all-cause mortality | USB Arm | 4 | 8 |
| Total, all-cause mortality | Marrow Clinimacs | 1 | 2 |
| Total, all-cause mortality | Sibling withoutCliniMACS | 0 | 1 |
| Total, other adverse events | Marrow Isolex | 3 | 3 |
| Total, other adverse events | USB Arm | 7 | 8 |
| Total, other adverse events | Marrow Clinimacs | 2 | 2 |
| Total, other adverse events | Sibling withoutCliniMACS | 1 | 1 |
| Total, serious adverse events | Marrow Isolex | 2 | 3 |
| Total, serious adverse events | USB Arm | 2 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT00258427
GET https://conductscience.org/api/trials/v1/NCT00258427/results?page=2