Comparison · NCT00719888-sae
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide vs Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa: serious adverse events
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: High-dose TBI + Fludarabine + Cyclophosphamide vs Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa: serious adverse events. Trial comparisons, record NCT00719888-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00719888-sae
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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 | 0.435 | 0.346 | 0.529 | wilson | |
| Risk in group 2 | 0.259 | 0.132 | 0.447 | wilson | |
| Risk difference, group 1 minus group 2 | 0.176 | -0.0319 | 0.334 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.68 | 0.857 | 3.29 | log | |
| Odds ratio, group 1 over group 2 | 2.2 | 0.859 | 5.64 | log | |
Number needed to harm, for one more participant with a serious adverse event on Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide than on Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa | 5.68 | 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: High-dose TBI + Fludarabine + Cyclophosphamide | Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0.~Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD.~Cyclophosphamide: Given IV~Cyclosporine: Given IV and PO~Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT~Fludarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV and PO~Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI~Umbilical Cord Blood Transplantation: Undergo UCBT | 47 | 108 | EG000 |
| Group 2 | Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa | Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0.~Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD.~Cyclophosphamide: Given IV~Cyclosporine: Given IV and PO~Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT~Fludarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV and PO~Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI~Umbilical Cord Blood Transplantation: Undergo UCBT~Thiotepa: Given IV | 7 | 27 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death.
Source ClinicalTrials.gov
Trial
- Title
- Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease
- NCT number
- NCT00719888
- Phases
- PHASE2
- Conditions
Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Burkitt Lymphoma, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Follicular Lymphoma, Lymphoblastic Lymphoma, Lymphoplasmacytic Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Myelodysplastic Syndrome, Myelofibrosis, Non-Hodgkin Lymphoma, Plasma Cell Myeloma, Prolymphocytic Leukemia, Refractory Anemia, Small Lymphocytic Lymphoma
- Interventions
Cyclophosphamide, Cyclosporine, Double-Unit Umbilical Cord Blood Transplantation, Fludarabine, Laboratory Biomarker Analysis, Mycophenolate Mofetil, Total-Body Irradiation, Umbilical Cord Blood Transplantation, Thiotepa
- Lead sponsor
- Fred Hutchinson Cancer Center
- Results first posted
- 2025-03-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00719888?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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