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Comparison · NCT00919503-8cc5945f

Regimen A (PBSCT and BMT) vs Regimen B (UBCT): Number of Participants With Infections

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 Participants With Infections. Trial comparisons, record NCT00919503-8cc5945f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00919503-8cc5945f

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.6790.5730.769wilson
Risk in group 20.6430.3880.837wilson
Risk difference, group 1 minus group 20.0357-0.1850.306newcombe hybrid score
Risk ratio, group 1 over group 21.060.6951.6log
Odds ratio, group 1 over group 21.170.3593.84log
Number needed to treat, for one more participant with the outcome on Regimen A (PBSCT and BMT) than on Regimen B (UBCT)28from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Regimen 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
5784OG000
Group 2Regimen 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
914OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Infections
Description
Number of participants with clinically significant infections (bacterial, fungal, viral) requiring treatment within 100 days following transplant
Time frame
100 days post transplant
Population

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

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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