Comparison · NCT00919503-48ec18fc
Regimen A (PBSCT and BMT) vs Regimen B (UBCT): Number of Patients With of Chronic Graft-versus-host Disease
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Regimen A (PBSCT and BMT) vs Regimen B (UBCT): Number of Patients With of Chronic Graft-versus-host Disease. Trial comparisons, record NCT00919503-48ec18fc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00919503-48ec18fc
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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 | 0.345 | 0.252 | 0.452 | wilson | |
| Risk in group 2 | 0.455 | 0.213 | 0.72 | wilson | |
| Risk difference, group 1 minus group 2 | -0.109 | -0.39 | 0.155 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.76 | 0.373 | 1.55 | log | |
| Odds ratio, group 1 over group 2 | 0.633 | 0.178 | 2.25 | log | |
| Number needed to treat, for one fewer participant with the outcome on Regimen A (PBSCT and BMT) than on Regimen B (UBCT) | 9.15 | from the risk difference interval | the interval includes no difference |
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 | Regimen A (PBSCT and BMT) | CONDITIONING REGIMEN A : Patients receive treosulfan IV on days -6 to -4 and fludarabine phosphate IV on days -6 to -2. Patients receive anti-thymocyte globulin IV on days -4 to -2. Patients undergoing umbilical cord blood transplantation will also receive low dose total-body irradiation on day -1.~TRANSPLANTATION: Patients receive either bone marrow, peripheral blood stem cells (PBSC), or umbilical cord blood from the donor on day 0. The use of either bone marrow, PBSC, or umbilical cord blood will depend on the donor status.~Patients undergoing bone marrow or PBSC transplantation receive tacrolimus IV continuously or PO twice daily on days -1 to 50 followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.~Allogeneic Bone Marrow Transplantation: Infused IV~Anti-Thymocyte Globulin: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IV~Peripheral Blood Stem Cell Transplantation: Infused IV~Tacrolimus: Given IV or PO~Treosulfan: Given IV | 29 | 84 | OG000 |
| Group 2 | Regimen B (UBCT) | CONDITIONING REGIMEN B: Patients receive treosulfan IV on days -6 to -4 and fludarabine phosphate IV on days -6 to -2. Patients receive anti-thymocyte globulin IV on days -4 to -2. Patients undergoing umbilical cord blood transplantation will also receive low dose total-body irradiation on day -1 .~TRANSPLANTATION: Patients receive either bone marrow, peripheral blood stem cells (PBSC), or umbilical cord blood from the donor on day 0. The use of either bone marrow, PBSC, or umbilical cord blood will depend on the donor status.~Patients undergoing UCB transplantation receive cyclosporine IV over 1 hour every 8-12 hours on days -3 to 100 followed by a taper until day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil IV or PO every 8 hours on days 0 to 40 followed by a taper until day 96 in the absence of GVHD.~Anti-Thymocyte Globulin: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV or PO~Total-Body Irradiation: Undergo total body irradiation~Treosulfan: Given IV~Umbilical Cord Blood Transplantation: Single or double unit umbilical cord blood transplant, infused IV | 5 | 11 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients With of Chronic Graft-versus-host Disease
- Description
- Number of patients diagnosed with chronic GVHD and requiring systemic immunosuppression within 1 year following transplant
- Time frame
- 1 year following transplant
- Population
- Regimen B: 3 patients expired too early for evaluation for chronic GVHD and could not be evaluated for this outcome
Source ClinicalTrials.gov
Trial
- Title
- Treosulfan and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Nonmalignant Inherited Disorders
- NCT number
- NCT00919503
- Phases
- PHASE2
- Conditions
- Non-Neoplastic Hematologic and Lymphocytic Disorder
- Interventions
Allogeneic Bone Marrow Transplantation, Anti-Thymocyte Globulin, Cyclosporine, Fludarabine Phosphate, Laboratory Biomarker Analysis, Methotrexate, Mycophenolate Mofetil, Peripheral Blood Stem Cell Transplantation, Tacrolimus, Total-Body Irradiation, Treosulfan, Umbilical Cord Blood Transplantation
- Lead sponsor
- Fred Hutchinson Cancer Center
- Results first posted
- 2021-08-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00919503?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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