Trial · NCT00352976
TBI Dose De-escalation for Fanconi Anemia
NCT00352976, Phase 2, Phase 3, Completed, Masonic Cancer Center, University of Minnesota; results first posted 2021-11-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TBI Dose De-escalation for Fanconi Anemia. Trials, record NCT00352976. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00352976
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TBI Dose De-escalation for Fanconi Anemia
- NCT number
- NCT00352976
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 83 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Fanconi Anemia
- Interventions
- Cyclophosphamide, Fludarabine, Total Body Irradiation, Bone Marrow Transplantation, Mycophenolate Mofetil, Sirolimus
- First posted
- 2006-07-17
- Last updated
- 2021-11-24
- Results first posted
- 2021-11-24
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participant With Neutrophil Recovery | by day 42 | Number of participant with neutrophil recovery. Neutrophil recovery is defined as absolute neutrophil count ≥500/µL for three consecutive days |
| Secondary | Number of Participants Experiencing Grade ≥3 Regimen Related Toxicity | by day 100 | Regimen related toxicities (RRT) include: significant hemorrhagic cystitis, pulmonary hemorrhage, interstitial pneumonitis, GI hemorrhage, renal failure, erythroderma, and severe hepatic veno-occlusive disease |
| Secondary | Number of Participants With Secondary Graft Failure at 100 Days | 100 days | Secondary Graft Rejection by day 100 |
| Secondary | Number of Participants Experiencing Acute Graft-versus-host Disease (GVHD) | at 100 days | Number of participants experiencing acute GVHD (all grades) by day 100 |
| Secondary | Number of Participants Experiencing Chronic GVHD | at one year | Number of participants experiencing chronic Graft Vs Host Disease by 1 year |
| Secondary | Number of Participants Experiencing Overall Survival | at one year | Number of participants experiencing overall survival by 1 year |
| Secondary | Number of Participants Experiencing Infections by Day 100 | by day 100 | |
| Secondary | Number of Participants Experiencing Infections by Day 180 | by day 180 | |
| Secondary | Number of Participants Experiencing Infections by Day 365 | by day 365 | |
| Secondary | Average Immunoglobulin G (IgG) Levels as a Measure of Immune Reconstitution After Transplant, by 100 Days | by 100 days |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participant With Neutrophil Recovery | by day 42 | 1 patient not evaluable since deceased at day 5 post transplant | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Grade ≥3 Regimen Related Toxicity | by day 100 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Secondary Graft Failure at 100 Days | 100 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Acute Graft-versus-host Disease (GVHD) | at 100 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Chronic GVHD | at one year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Overall Survival | at one year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Infections by Day 100 | by day 100 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Infections by Day 180 | by day 180 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Infections by Day 365 | by day 365 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Average Immunoglobulin G (IgG) Levels as a Measure of Immune Reconstitution After Transplant, by 100 Days | by 100 days | mg/dL | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participant With Neutrophil Recovery | Treatment With TBI | 78 | Participants | ||
| Number of Participants Experiencing Grade ≥3 Regimen Related Toxicity | Treatment With TBI | 71 | Participants | ||
| Number of Participants With Secondary Graft Failure at 100 Days | Treatment With TBI | 4 | Participants | ||
| Number of Participants Experiencing Acute Graft-versus-host Disease (GVHD) | Treatment With TBI | 15 | Participants | ||
| Number of Participants Experiencing Chronic GVHD | Treatment With TBI | 6 | Participants | ||
| Number of Participants Experiencing Overall Survival | Treatment With TBI | 70 | Participants | ||
| Number of Participants Experiencing Infections by Day 100 | Treatment With TBI | 53 | Participants | ||
| Number of Participants Experiencing Infections by Day 180 | Treatment With TBI | 55 | Participants | ||
| Number of Participants Experiencing Infections by Day 365 | Treatment With TBI | 56 | Participants | ||
| Average Immunoglobulin G (IgG) Levels as a Measure of Immune Reconstitution After Transplant, by 100 Days | Treatment With TBI | 550.6 | Standard Deviation 285.4 | mg/dL |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment With TBI | 83 | |
| Overall Study | COMPLETED | Treatment With TBI | 83 | |
| Overall Study | NOT COMPLETED | Treatment With TBI | 0 |
Source ClinicalTrials.gov
Adverse events70
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 | Anemia | Blood and lymphatic system disorders | Treatment With TBI | 1 | 83 | 1 |
| other | Injury, poisoning and procedural complications, other | Blood and lymphatic system disorders | Treatment With TBI | 1 | 83 | 1 |
| other | Investigations, other | Blood and lymphatic system disorders | Treatment With TBI | 1 | 83 | 1 |
| other | Thrombosis | Blood and lymphatic system disorders | Treatment With TBI | 3 | 83 | 5 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Treatment With TBI | 1 | 83 | 1 |
| other | hemolysis | Blood and lymphatic system disorders | Treatment With TBI | 1 | 83 | 1 |
| other | hypoatremia | Blood and lymphatic system disorders | Treatment With TBI | 1 | 83 | 1 |
| other | neurotoxicity | Blood and lymphatic system disorders | Treatment With TBI | 1 | 83 | 1 |
| other | cardiomegaly | Cardiac disorders | Treatment With TBI | 1 | 83 | 1 |
| other | myringotomy | Ear and labyrinth disorders | Treatment With TBI | 1 | 83 | 1 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment With TBI | 13 | 83 |
| Total, other adverse events | Treatment With TBI | 75 | 83 |
| Total, serious adverse events | Treatment With TBI | 4 | 83 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25824692 | BACKGROUND |
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/NCT00352976
GET https://conductscience.org/api/trials/v1/NCT00352976/events?page=2