Trial · NCT00590460
Antibody Conditioning Regimen For Allogeneic Donor Stem Cell Transplantation Of Patients With Fanconi Anemia
NCT00590460, Phase 1, Phase 2, Terminated, Baylor College of Medicine; results first posted 2012-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Antibody Conditioning Regimen For Allogeneic Donor Stem Cell Transplantation Of Patients With Fanconi Anemia. Trials, record NCT00590460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00590460
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antibody Conditioning Regimen For Allogeneic Donor Stem Cell Transplantation Of Patients With Fanconi Anemia
- NCT number
- NCT00590460
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Fanconi Anemia, Severe Aplastic Anemia
- Interventions
- CAMPATH-1H, Anti-CD45, Fludarabine, Stem cell infusion
- First posted
- 2008-01-10
- Last updated
- 2018-05-24
- Results first posted
- 2012-08-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Donor Engraftment | 100 Days | Number of patients with engraftment of at least 65% of donor cells 100 days after transplantation |
| Secondary | Number of Patients With Graft Failure | 100 days | Graft failure is defined as engraftment of less than 65% of donor cells 100 days after transplantation. |
| Secondary | Patients With Treated Related Death | 100 days | Number of patients with treated related death |
| Secondary | Days to Absolute Neutrophil Count (ANC) of 500/mm3 | 30 Days | Number of days to Absolute neutrophil count (ANC) of 500/mm3 |
| Secondary | Days to Platelet Count of 20,000/mm3 Without Transfusions | 30 Days | Number of days to Platelet count of 20,000 / mm3 without transfusions |
| Secondary | Patients With Grade II - IV Acute Graft Versus Host Disease (GVHD) | 100 days | Number of patients with grade II - IV acute Graft versus Host Disease (GVHD) |
| Secondary | Number of Patients Alive at 1 Year Post Transplant | 1 year | Number of patients alive at 1 year post allogeneic stem cell transplant |
| Secondary | Patients With Limited Chronic GVHD From Day 100 to 365 | 365 days | Number of patients with limited chronic GVHD from day 100 to 365 |
| Secondary | Patients With Extensive Chronic GVHD From Day 100 to 365 | 365 days | Number of patients with extensive chronic GVHD from day 100 to 365. |
| Secondary | Patients With Grade III - IV Acute GVHD | 100 days | Number of patients with Grade III-IV acute GVHD |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Donor Engraftment | 100 Days | participants | NUMBER | |
| SECONDARY | Number of Patients With Graft Failure | 100 days | participants | NUMBER | |
| SECONDARY | Patients With Treated Related Death | 100 days | participants | NUMBER | |
| SECONDARY | Days to Absolute Neutrophil Count (ANC) of 500/mm3 | 30 Days | days | MEDIAN | |
| SECONDARY | Days to Platelet Count of 20,000/mm3 Without Transfusions | 30 Days | Participants achieved a platelet count of 20,000 / mm3 without transfusions. | days | MEDIAN |
| SECONDARY | Patients With Grade II - IV Acute Graft Versus Host Disease (GVHD) | 100 days | participants | NUMBER | |
| SECONDARY | Number of Patients Alive at 1 Year Post Transplant | 1 year | participants | NUMBER | |
| SECONDARY | Patients With Limited Chronic GVHD From Day 100 to 365 | 365 days | participants | NUMBER | |
| SECONDARY | Patients With Extensive Chronic GVHD From Day 100 to 365 | 365 days | participants | NUMBER | |
| SECONDARY | Patients With Grade III - IV Acute GVHD | 100 days | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Donor Engraftment | Allogeneic Stem Cell Transplant | 2 | participants | ||
| Number of Patients With Graft Failure | Allogeneic Stem Cell Transplant | 3 | participants | ||
| Patients With Treated Related Death | Allo Stem Cell Transplant | 0 | participants | ||
| Days to Absolute Neutrophil Count (ANC) of 500/mm3 | Allogeneic Stem Cell Transplant | 15 | Full Range 14 to 16 | days | |
| Days to Platelet Count of 20,000/mm3 Without Transfusions | Allogeneic Stem Cell Transplant | 16 | Full Range 14 to 18 | days | |
| Patients With Grade II - IV Acute Graft Versus Host Disease (GVHD) | Allogeneic Stem Cell Transplant | 0 | participants | ||
| Number of Patients Alive at 1 Year Post Transplant | Allogeneic Stem Cell Transplant | 5 | participants | ||
| Patients With Limited Chronic GVHD From Day 100 to 365 | Allogeneic Stem Cell Transplant | 0 | participants | ||
| Patients With Extensive Chronic GVHD From Day 100 to 365 | Allogeneic Stem Cell Transplant | 0 | participants | ||
| Patients With Grade III - IV Acute GVHD | Allogeneic Stem Cell Transplant | 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 | Allo Stem Cell Transplant | 5 | |
| Overall Study | COMPLETED | Allo Stem Cell Transplant | 5 | |
| Overall Study | NOT COMPLETED | Allo Stem Cell Transplant | 0 |
Source ClinicalTrials.gov
Adverse events9
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 | Group1 | 3 | 5 | 3 |
| other | Anorexia | Gastrointestinal disorders | Group1 | 1 | 5 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Group1 | 1 | 5 | 1 |
| other | AST | Hepatobiliary disorders | Group1 | 2 | 5 | 4 |
| other | Picorna virus sinusitis | Infections and infestations | Group1 | 1 | 5 | 1 |
| other | Herpes simplex type I | Infections and infestations | Group1 | 1 | 5 | 1 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Group1 | 2 | 5 | 5 |
| other | Jaw Pain | General disorders | Group1 | 1 | 5 | 1 |
| serious | CNC hemorrhage | Nervous system disorders | Group1 | 1 | 5 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group1 | ||
| Total, other adverse events | Group1 | 5 | 5 |
| Total, serious adverse events | Group1 | 1 | 5 |
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/NCT00590460
GET https://conductscience.org/api/trials/v1/NCT00590460/registered