Trial · NCT00167206
Stem Cell Transplantation for Fanconi Anemia
NCT00167206, Phase 1, Phase 2, Terminated, Masonic Cancer Center, University of Minnesota; results first posted 2009-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stem Cell Transplantation for Fanconi Anemia. Trials, record NCT00167206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00167206
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stem Cell Transplantation for Fanconi Anemia
- NCT number
- NCT00167206
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Fanconi Anemia
- Interventions
- Hematopoietic Stem Cell Transplant, Thymic Shielding During Radiation, Total Body Irradiation, Cyclophosphamide, Fludarabine
- First posted
- 2005-09-14
- Last updated
- 2019-08-26
- Results first posted
- 2009-11-26
- Limitations and caveats
- Study ended early as thymic shielding was found to be safe. Therefore, a new study was designed using thymic shielding.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Exhibited Hematopoietic Recovery and Engraftment | Day 42 after hematopoietic cell transplant | Calculated from Day 1 of hematopoietic cell transplant to Day 42 post-transplant. Hematopoietic recovery and engraftment is defined as the first of three consecutive days the patient's absolute neutrophil count is greater than or equal to 0.5X10\^9/Liter. |
| Secondary | Number of Patients Who Exhibited Secondary Graft Failure | Day 100 after hematopoietic cell transplant | Calculated from Day 1 of hematopoietic cell transplant to Day 100 after transplant. A complication after Bone Marrow Transplant in which the transplanted stem cells do not grow in the recipient's bone marrow and thus do not produce new blood cells. |
| Secondary | Number of Patients With Acute Graft Versus-Host Disease (aGVHD) | Day 100 after hematopoietic cell transplant | Calculated from Day 1 of hematopoietic cell transplant to Day 100 after transplant. GVHD is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack. |
| Secondary | Number of Patients With Chronic Graft Versus-Host Disease (GVHD) | 1 year after hematopoietic cell transplant | Calculated from Day 1 of hematopoietic cell transplant to 1 year after transplant. GVHD is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack. |
| Secondary | Number of Patients Who Exhibited Regimen-related Toxicity (RRT) | 1 year after hematopoietic cell transplant | Calculated from Day 1 of hematopoietic cell transplant to 1 year after transplant. Regimen-related toxicity involves harmful effects in an organism through exposure to the treatment given. |
| Secondary | Immune Reconstitution - Mean Value (1 Year) | 1 year post-transplant. | Calculated mean value of patient CD4 values collected at intervals from Day 30 through 1 year post-transplant. |
| Secondary | Immune Reconstitution - Mean Value (2 Years) | at 2 years after transplant | Calculated mean value of patient CD4 values collected at intervals from Day 30 through 2 years post-transplant. |
| Secondary | Number of Patients Alive at 1 Year | 1 year after transplant | Calculated from Day 1 of hematopoietic cell transplant to 1 year post-transplant. |
| Secondary | Number of Patients Alive at 2 Years | 2 years after transplant | Calculated from Day 1 of hematopoietic cell transplant to 2 years post-transplant. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who Exhibited Hematopoietic Recovery and Engraftment | Day 42 after hematopoietic cell transplant | Participants | NUMBER | |
| SECONDARY | Number of Patients Who Exhibited Secondary Graft Failure | Day 100 after hematopoietic cell transplant | Participants | NUMBER | |
| SECONDARY | Number of Patients With Acute Graft Versus-Host Disease (aGVHD) | Day 100 after hematopoietic cell transplant | Participants | NUMBER | |
| SECONDARY | Number of Patients With Chronic Graft Versus-Host Disease (GVHD) | 1 year after hematopoietic cell transplant | Participants | NUMBER | |
| SECONDARY | Number of Patients Who Exhibited Regimen-related Toxicity (RRT) | 1 year after hematopoietic cell transplant | Participants | NUMBER | |
| SECONDARY | Immune Reconstitution - Mean Value (1 Year) | 1 year post-transplant. | Number of CD4 cells per microliter | MEAN | |
| SECONDARY | Immune Reconstitution - Mean Value (2 Years) | at 2 years after transplant | Number of CD4 cells per microliter | MEAN | |
| SECONDARY | Number of Patients Alive at 1 Year | 1 year after transplant | Participants | NUMBER | |
| SECONDARY | Number of Patients Alive at 2 Years | 2 years after transplant | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Who Exhibited Hematopoietic Recovery and Engraftment | Intent-To-Treat | 15 | Participants | ||
| Number of Patients Who Exhibited Secondary Graft Failure | Intent-To-Treat | 1 | Participants | ||
| Number of Patients With Acute Graft Versus-Host Disease (aGVHD) | Intent-To-Treat | 8 | Participants | ||
| Number of Patients With Chronic Graft Versus-Host Disease (GVHD) | Intent-To-Treat | 2 | Participants | ||
| Number of Patients Who Exhibited Regimen-related Toxicity (RRT) | Intent-To-Treat | 5 | Participants | ||
| Immune Reconstitution - Mean Value (1 Year) | Intent-To-Treat | 860 | Standard Deviation 870 | Number of CD4 cells per microliter | |
| Immune Reconstitution - Mean Value (2 Years) | Intent-To-Treat | 1100 | Standard Deviation 510 | Number of CD4 cells per microliter | |
| Number of Patients Alive at 1 Year | Intent-To-Treat | 11 | Participants | ||
| Number of Patients Alive at 2 Years | Intent-To-Treat | 10 | 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 | Intent-To-Treat | 16 | |
| Overall Study | COMPLETED | Intent-To-Treat | 16 | |
| Overall Study | NOT COMPLETED | Intent-To-Treat | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intent-To-Treat | ||
| Total, other adverse events | Intent-To-Treat | 0 | 0 |
| Total, serious adverse events | Intent-To-Treat | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25824692 | DERIVED |
Source PubMed
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/NCT00167206
GET https://conductscience.org/api/trials/v1/NCT00167206/registered