Trial · NCT05579769
Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies.
NCT05579769, Phase 2, Terminated, St. Jude Children's Research Hospital; results first posted 2025-10-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies. Trials, record NCT05579769. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05579769
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies.
- NCT number
- NCT05579769
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- 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
- First posted
- 2022-10-14
- Last updated
- 2025-10-02
- Results first posted
- 2025-10-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 100 days post transplant | 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. |
| Secondary | Cumulative Incidence of Overall Survival (OS) | One-year post-transplantation. | The one-year survival is defined by the participant who has not died within one year after post transplantation. The rate is calculated by computing the ratio between total number of one year survival patients and the total number of patients. |
| Secondary | Cumulative Incidence of Relapse | One-year post-transplantation. | Bone marrow studies for disease status evaluation will be performed at 1-year post-transplant. Testing will include a research evaluation for minimal residual disease. |
| Secondary | Cumulative Incidence of Non Relapse Mortality (NRM) | One-year post-transplantation. | Non-relapse mortality is death without evidence of disease relapse or progression. The rate is calculated by computing the ratio between total number of NRM patients and the total number of patients. |
| Secondary | Cumulative Incidence of Chronic GVHD | One-year post-transplantation. | Chronic graft-vs-host disease will be evaluated using the standard grading criteria. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | 100 days post transplant | None of the 3 participants had saGVHD. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Incidence of Overall Survival (OS) | One-year post-transplantation. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cumulative Incidence of Relapse | One-year post-transplantation. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cumulative Incidence of Non Relapse Mortality (NRM) | One-year post-transplantation. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cumulative Incidence of Chronic GVHD | One-year post-transplantation. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Total Body Irradiation (TBI)/Cyclophosphamide (Cy) | 0 | Participants | ||
| 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. | Thiotepa, Busulfan, and Fludarabine (TBF) | 0 | Participants | ||
| Cumulative Incidence of Overall Survival (OS) | Total Body Irradiation (TBI)/Cyclophosphamide (Cy) | 1 | Participants | ||
| Cumulative Incidence of Overall Survival (OS) | Thiotepa, Busulfan, and Fludarabine (TBF) | 1 | Participants | ||
| Cumulative Incidence of Relapse | Total Body Irradiation (TBI)/Cyclophosphamide (Cy) | 0 | Participants | ||
| Cumulative Incidence of Relapse | Thiotepa, Busulfan, and Fludarabine (TBF) | 0 | Participants | ||
| Cumulative Incidence of Non Relapse Mortality (NRM) | Total Body Irradiation (TBI)/Cyclophosphamide (Cy) | 0 | Participants | ||
| Cumulative Incidence of Non Relapse Mortality (NRM) | Thiotepa, Busulfan, and Fludarabine (TBF) | 0 | Participants | ||
| Cumulative Incidence of Chronic GVHD | Total Body Irradiation (TBI)/Cyclophosphamide (Cy) | 0 | Participants | ||
| Cumulative Incidence of Chronic GVHD | Thiotepa, Busulfan, and Fludarabine (TBF) | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total Body Irradiation (TBI)/Cyclophosphamide (Cy) | 2 | |
| Overall Study | STARTED | Thiotepa, Busulfan, and Fludarabine (TBF) | 1 | |
| Overall Study | COMPLETED | Total Body Irradiation (TBI)/Cyclophosphamide (Cy) | 1 | |
| Overall Study | COMPLETED | Thiotepa, Busulfan, and Fludarabine (TBF) | 1 | |
| Overall Study | NOT COMPLETED | Total Body Irradiation (TBI)/Cyclophosphamide (Cy) | 1 | |
| Overall Study | NOT COMPLETED | Thiotepa, Busulfan, and Fludarabine (TBF) | 0 |
Source ClinicalTrials.gov
Adverse events76
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood and lymphatic system disorders - Other, specify (Thrombotic Microangiopathy) | Blood and lymphatic system disorders | TBI/Cy Regimen | 1 | 2 | 1 |
| other | Blood and lymphatic system disorders - Other, specify (Thrombotic Microangiopathy) | Blood and lymphatic system disorders | TBF Regimen | 1 | 1 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | TBI/Cy Regimen | 0 | 2 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | TBF Regimen | 1 | 1 | 1 |
| other | Enterocolitis | Gastrointestinal disorders | TBI/Cy Regimen | 0 | 2 | 0 |
| other | Enterocolitis | Gastrointestinal disorders | TBF Regimen | 1 | 1 | 1 |
| other | Ileus | Gastrointestinal disorders | TBI/Cy Regimen | 1 | 2 | 1 |
| other | Ileus | Gastrointestinal disorders | TBF Regimen | 0 | 1 | 0 |
| other | Mucositis oral | Gastrointestinal disorders | TBI/Cy Regimen | 0 | 2 | 0 |
| other | Mucositis oral | Gastrointestinal disorders | TBF Regimen | 1 | 1 | 1 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TBI/Cy Regimen | 1 | 2 |
| Total, all-cause mortality | TBF Regimen | 0 | 1 |
| Total, other adverse events | TBI/Cy Regimen | 2 | 2 |
| Total, other adverse events | TBF Regimen | 1 | 1 |
| Total, serious adverse events | TBI/Cy Regimen | 2 | 2 |
| Total, serious adverse events | TBF Regimen | 1 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
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 |
| Total Body Irradiation (TBI)/Cyclophosphamide (Cy) vs Thiotepa, Busulfan, and Fludarabine (TBF): Cumulative Incidence of Relapse | Trial comparisons |
| Total Body Irradiation (TBI)/Cyclophosphamide (Cy) vs Thiotepa, Busulfan, and Fludarabine (TBF): Cumulative Incidence of Non Relapse Mortality (NRM) | Trial comparisons |
| Total Body Irradiation (TBI)/Cyclophosphamide (Cy) vs Thiotepa, Busulfan, and Fludarabine (TBF): Cumulative Incidence of Chronic GVHD | Trial comparisons |
| Total Body Irradiation (TBI)/Cyclophosphamide (Cy) vs Thiotepa, Busulfan, and Fludarabine (TBF): Cumulative Incidence of Overall Survival (OS) | Trial comparisons |
| TBI/Cy Regimen vs TBF Regimen: deaths from any cause | Trial comparisons |
| TBI/Cy Regimen vs TBF Regimen: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05579769
GET https://conductscience.org/api/trials/v1/NCT05579769/events?page=2