Comparison · NCT00455312-e0027b5f
Patients With DC vs Patients With SAA: Neutrophil Engraftment
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Patients With DC vs Patients With SAA: Neutrophil Engraftment. Trial comparisons, record NCT00455312-e0027b5f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00455312-e0027b5f
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 1 | 0.796 | 1 | wilson | |
| Risk in group 2 | 1 | 0.839 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.204 | 0.161 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Patients With DC | Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0. | 15 | 15 | OG000 |
| Group 2 | Patients With SAA | Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG. | 20 | 20 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Neutrophil Engraftment
- Description
Defined as an absolute neutrophil count (ANC) \>5 x 10\^8/L (first of three consecutive laboratory measurements on different days) with at least 10% donor cells by day 100. Demonstrate sustained engraftment after a fludarabine based preparative regimen in patients with dyskeratosis congenita followed by hematopoietic cell transplantation.
- Time frame
- Day 100
- Population
Source ClinicalTrials.gov
Trial
- Title
- Stem Cell Transplant (SCT) for Dyskeratosis Congenita or SAA
- NCT number
- NCT00455312
- Phases
- PHASE2, PHASE3
- Conditions
- Dyskeratosis Congenita, Aplastic Anemia
- Interventions
- Campath 1H, Cyclophosphamide, Fludarabine, Total Body Irradiation, Stem Cell Transplantation, antithymocyte globulin, Methylprednisolone
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Results first posted
- 2017-05-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00455312?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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GET https://conductscience.org/api/comparisons/v1/NCT00455312-e0027b5f