Comparison · NCT05579769-sae
TBI/Cy Regimen vs TBF Regimen: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Download JSON
Cite this record
ConductScience Library. TBI/Cy Regimen vs TBF Regimen: serious adverse events. Trial comparisons, record NCT05579769-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05579769-sae
On this page
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 | 1 | 0.342 | 1 | wilson | |
| Risk in group 2 | 1 | 0.207 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.658 | 0.793 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | TBI/Cy Regimen | Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy).~Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.~Participants receive 8 doses TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI.~Patients who receive a bone marrow product from MSD will not receive rATG.~G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is \>500 cells/mm3, and ANC is\<500 cells/mm3 to mobilize cells.~Mesna: Mesna will be given IV approximately 15 minutes prior to each dose of cyclophosphamide and approximately 3, 6, 9, and 12 hours after each dose of cyclophosphamide.~GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG. | 2 | 2 | EG000 |
| Group 2 | TBF Regimen | Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate.~Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.~Participants receive Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV.~Patients who receive a bone marrow product from MSD will not receive rATG.~G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is \>500 cells/mm3, and ANC is\<500 cells/mm3 to mobilize cells.~Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.~GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG. | 1 | 1 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Source ClinicalTrials.gov
Trial
- Title
- Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies.
- NCT number
- NCT05579769
- Phases
- PHASE2
- Conditions
- Hematologic Malignancy, Myeloid Malignancy
- Interventions
- Ruxolitinib, Mesna, Anti-thymocyte globulin (ATG), Cyclosporine, Cyclophosphamide, Fludarabine, Methotrexate, Total Body Irradiation (radiation treatment), Bone marrow infusion, Busulfan, Thiotepa
- Lead sponsor
- St. Jude Children's Research Hospital
- Results first posted
- 2025-10-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05579769?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT05579769-sae