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Comparison · NCT00796068-db549bdb

Arm I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): The Number of Participants Alive at Two-years Follow up.

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. Arm I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): The Number of Participants Alive at Two-years Follow up. Trial comparisons, record NCT00796068-db549bdb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00796068-db549bdb

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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 10.7580.6420.845wilson
Risk in group 20.6880.5660.788wilson
Risk difference, group 1 minus group 20.0701-0.08290.22newcombe hybrid score
Risk ratio, group 1 over group 21.10.8891.37log
Odds ratio, group 1 over group 21.420.6563.07log
Number needed to treat, for one more participant with the outcome on Arm I (Low Risk for Graft Failure) than on Arm II (High Risk for Graft Failure)14.3from 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 1Arm I (Low Risk for Graft Failure)
Patients receive a conditioning regimen comprising fludarabine phosphate IV over 1 hour QD on days -6 to -2 and treosulfan IV over 120 minutes on days - 6 to -4. Patients undergo TBI on day -1. Patients then undergo donor UCBT on day 0.~Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour or PO 2-3 times daily on days -3 to 100, followed by a taper in the absence of GVHD. Patients also receive mycophenolate mofetil IV 3 times daily on days 0 to 40, followed by a taper in the absence of GVHD.~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV~Total-Body Irradiation: TBI administered day -1: 200 cGy (or escalated to 300 cGy, 400 cGy, or 450 cGy per protocol statistical section)~Treosulfan: Given IV~Umbilical Cord Blood Transplantation: Undergo single or double unit UCBT
5066OG000
Group 2Arm II (High Risk for Graft Failure)
Patients receive a conditioning regimen, TBI, donor UCBT, GVHD prophylaxis, and mycophenolate mofetil as in Arm I.~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV~Total-Body Irradiation: TBI administered day -1: 200 cGy (or escalated to 300 cGy, 400 cGy, or 450 cGy per protocol statistical section)~Treosulfan: Given IV~Umbilical Cord Blood Transplantation: Undergo single or double unit UCBT
4464OG001

Outcome

Type
SECONDARY
Title
The Number of Participants Alive at Two-years Follow up.
Description
Overall survival of participants after two-years of follow up.
Time frame
Up to 2 years
Population

Source ClinicalTrials.gov

Trial

Title
Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematological Cancer Who Are Undergoing Umbilical Cord Blood Transplant
NCT number
NCT00796068
Phases
PHASE2
Conditions
Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Blasts Under 5 Percent of Bone Marrow Nucleated Cells, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Myelodysplastic Syndrome (MDS)
Interventions
Cyclosporine, Fludarabine Phosphate, Laboratory Biomarker Analysis, Mycophenolate Mofetil, Total-Body Irradiation, Treosulfan, Umbilical Cord Blood Transplantation
Lead sponsor
Fred Hutchinson Cancer Center
Results first posted
2023-02-17

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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