Trial · NCT00176878
Stem Cell Transplant for Bone Marrow Failure Syndromes
NCT00176878, Phase 2, Phase 3, Completed, Masonic Cancer Center, University of Minnesota; results first posted 2009-08-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stem Cell Transplant for Bone Marrow Failure Syndromes. Trials, record NCT00176878. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00176878
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stem Cell Transplant for Bone Marrow Failure Syndromes
- NCT number
- NCT00176878
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 10 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Diamond-Blackfan Anemia, Kostmann's Neutropenia, Shwachman-Diamond Syndrome
- Interventions
- Stem cell transplant, Fludarabine monophosphate, Total lymphoid irradiation, Busulfan, anti-thymocyte globulin
- First posted
- 2005-09-15
- Last updated
- 2017-12-28
- Results first posted
- 2009-08-06
- Limitations and caveats
- Pharmacokinetic parameters in patients receiving 2 mg/kg/dose of busulfan twice daily was not performed. No data is available.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Alive (Survival) at 2 Years | 2 years | Calculated from day 1 of transplant to last contact. |
| Secondary | Number of Patients Alive at Three Years (Survival) | 3 years | Number of subjects who survived 3 years post-transplant. |
| Secondary | Number of Patients With Succcessful Engraftment After Transplantation | 42 Days | Number of patients who received non-genotypic identical marrow or cord blood cells using a "non-myeloablative" preparative regimen and exhibited engraftment at Day 42. |
| Secondary | Number of Patients With Grade 2-4 Acute Graft Versus Host Disease | 100 Days | Number of patients with Grade 2, 3 and 4 Acute (normally observed within the first 100 days) Graft Versus Host Disease. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of 1 to a high of 4. Patients with grade IV GVHD usually have a poor prognosis. Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. |
| Secondary | Number of Patients With Chronic Graft Versus Host Disease | 2 years | Number of patients who exhibited chronic (normally occurs after 100 days) Graft Versus Host Disease at 2 years post transplant. Chronic graft-versus-host-disease, over its long-term course, can also cause damage to the connective tissue and exocrine glands. |
| Secondary | Number of Patients With Disease Recurrence | 2 years | Number of patients who exhibited disease recurrence at 2 years. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Alive (Survival) at 2 Years | 2 years | Participants | NUMBER | |
| SECONDARY | Number of Patients Alive at Three Years (Survival) | 3 years | Participants | NUMBER | |
| SECONDARY | Number of Patients With Succcessful Engraftment After Transplantation | 42 Days | Participants | NUMBER | |
| SECONDARY | Number of Patients With Grade 2-4 Acute Graft Versus Host Disease | 100 Days | Participants | NUMBER | |
| SECONDARY | Number of Patients With Chronic Graft Versus Host Disease | 2 years | Participants | NUMBER | |
| SECONDARY | Number of Patients With Disease Recurrence | 2 years | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Alive (Survival) at 2 Years | Bone Marrow Failure Patients | 6 | Participants | ||
| Number of Patients Alive at Three Years (Survival) | Bone Marrow Failure Patients | 6 | Participants | ||
| Number of Patients With Succcessful Engraftment After Transplantation | Bone Marrow Failure Patients | 10 | Participants | ||
| Number of Patients With Grade 2-4 Acute Graft Versus Host Disease | Bone Marrow Failure Patients | 5 | Participants | ||
| Number of Patients With Chronic Graft Versus Host Disease | Bone Marrow Failure Patients | 3 | Participants | ||
| Number of Patients With Disease Recurrence | Bone Marrow Failure Patients | 0 | 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 | Bone Marrow Failure Patients | 10 | |
| Overall Study | COMPLETED | Bone Marrow Failure Patients | 10 | |
| Overall Study | NOT COMPLETED | Bone Marrow Failure Patients | 0 |
Source ClinicalTrials.gov
Adverse events3
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 |
|---|---|---|---|---|---|---|
| serious | Bone marrow graft failure | Blood and lymphatic system disorders | Bone Marrow Failure Patients | 3 | 10 | 3 |
| serious | Death | General disorders | Bone Marrow Failure Patients | 3 | 10 | 3 |
| serious | Graft-versus-host disease (acute) | Blood and lymphatic system disorders | Bone Marrow Failure Patients | 1 | 10 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bone Marrow Failure Patients | ||
| Total, other adverse events | Bone Marrow Failure Patients | 0 | 10 |
| Total, serious adverse events | Bone Marrow Failure Patients | 5 | 10 |
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/NCT00176878
GET https://conductscience.org/api/trials/v1/NCT00176878/registered