Comparison · NCT05579769-111f1fc0
Total Body Irradiation (TBI)/Cyclophosphamide (Cy) vs Thiotepa, Busulfan, and Fludarabine (TBF): Proportion of saGVHD Using a ProphylaxisRegimen With no Calcineurin Inhibitors After Day 100 Post First Allogeneic HLA-Matched Sibling or Unrelated Donor HCT for Hematological Malignancies.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Total Body Irradiation (TBI)/Cyclophosphamide (Cy) vs Thiotepa, Busulfan, and Fludarabine (TBF): Proportion of saGVHD Using a ProphylaxisRegimen With no Calcineurin Inhibitors After Day 100 Post First Allogeneic HLA-Matched Sibling or Unrelated Donor HCT for Hematological Malignancies. Trial comparisons, record NCT05579769-111f1fc0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05579769-111f1fc0
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 | 0 | 0 | 0.658 | wilson | |
| Risk in group 2 | 0 | 0 | 0.793 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.793 | 0.658 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | 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 | Total Body Irradiation (TBI)/Cyclophosphamide (Cy) | 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.~TBI/Cy regimen: Participants receive 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 Rabbit ATG.~G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21.~Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide.~Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.~GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG. | 0 | 2 | OG000 |
| Group 2 | Thiotepa, Busulfan, and Fludarabine (TBF) | 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.~TBF regimen: Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV.~Patients who receive a bone marrow product from MSD will not receive Rabbit ATG.~G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21.~Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide.~Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.~GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG. | 0 | 1 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Proportion of saGVHD Using a ProphylaxisRegimen With no Calcineurin Inhibitors After Day 100 Post First Allogeneic HLA-Matched Sibling or Unrelated Donor HCT for Hematological Malignancies.
- Description
Development of Severe Acute GVHD (saGVHD) at or before Day 100 post transplant is considered as an event. Severe acute GVHD is defined as grade II-IVGVHD. Acute graft-vs-host disease will be evaluated using the standard grading criteria.
- Time frame
- 100 days post transplant
- Population
- None of the 3 participants had saGVHD.
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/NCT05579769-111f1fc0