Comparison · NCT00067002-ecb56c91
Un-Manipulated CB Arm vs Expanded CB Arm: Number of Participants With Engraftment
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. Un-Manipulated CB Arm vs Expanded CB Arm: Number of Participants With Engraftment. Trial comparisons, record NCT00067002-ecb56c91. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00067002-ecb56c91
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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 | 0.865 | 0.747 | 0.933 | wilson | |
| Risk in group 2 | 0.83 | 0.708 | 0.908 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0352 | -0.106 | 0.175 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.886 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 1.31 | 0.45 | 3.84 | log | |
| Number needed to treat, for one more participant with the outcome on Un-Manipulated CB Arm than on Expanded CB Arm | 28.4 | 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 | Un-Manipulated CB Arm | Transplantation of Two Unmanipulated CB units. Rituxan 375 mg/m2 IV Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3. | 45 | 52 | OG000 |
| Group 2 | Expanded CB Arm | Transplantation One Unmanipulated and One Expanded CB Unit. Rituxan: 375 mg/m2 IV on Day - 9 for CD20 + malignancies. Fludarabine 40 mg/m2 IV on Days -6 to -3. Cyclophosphamide 50 mg/kg IV on Day -6. Mesna 10 mg/kg IV before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). TBI Day -1 at 2 Gy. | 44 | 53 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Engraftment
- Description
Engraftment defined as a sustained absolute neutrophil count (ANC) \> 0.5 x 10\^9/L for at least 3 consecutive days. Engraftment Failure defined as ANC \<500/ul by day +42 and participant has no evidence of donor chimerism on bone marrow examination.
- Time frame
- First 100 days, evaluation and blood tests twice weekly
- Population
Source ClinicalTrials.gov
Trial
- Title
- Randomized Double Cord Blood Transplant Study
- NCT number
- NCT00067002
- Phases
- PHASE2
- Conditions
- Leukemia, Lymphocytic, Acute, Leukemia, Myelocytic, Acute, Leukemia, Myeloid, Chronic, Lymphoma, Non-Hodgkin
- Interventions
- Expanded allogeneic cord blood (CB), One Unmanipulated and One Expanded Cord Blood Unit, Rituxan, Melphalan, Thiotepa, Fludarabine, Cyclophosphamide, Mesna, Total body irradiation (TBI)
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2019-05-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00067002?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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