Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05579769 · ClinicalTrials.gov registry record · Phase 2
Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies.
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT05579769 is a Phase 2 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 3 participants.
The verdict
NCT05579769, a Phase 2 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
The participants are being asked to take part in this clinical trial because the participant have a lymphoid or myeloid based cancer diagnosis that requires a bone marrow transplant. Primary Objectives To estimate the incidence of severe acute GVHD (saGVHD) using a prophylaxis regimen with no calcineurin inhibitors after day +60 post first allogeneic Human Leukocyte antigen (HLA)-matched sibling or unrelated donor HCT for hematological malignancies. Secondary objective Determine the cumulative incidence of relapse, NRM, chronic GVHD, and OS in study participants at one year post-transplant. Exploratory objectives * To evaluate the pharmacokinetic/pharmacodynamic (PK/PD) profiles of ruxolitinib, fludarabine, and rATG. * To assess immune reconstitution in study participants within the first year post-HCT.
Interventions
- DRUG Cyclophosphamide
- DRUG Mesna
- DRUG Ruxolitinib
- DRUG Cyclosporine
- DRUG Anti-thymocyte globulin (ATG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2023-03-14 |
| Est. Completion | 2024-05-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05579769
The ClinicalTrials.gov registry entry for NCT05579769 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05579769 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05579769 about?
NCT05579769 is a clinical study titled "Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies.". The participants are being asked to take part in this clinical trial because the participant have a lymphoid or myeloid based cancer diagnosis that requires a bone marrow transplant. Primary Objectives To estimate the incidence of severe acute GVHD (saGVHD) using a prophylaxis regimen with no calc...
What is the current status of trial NCT05579769?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2023-03-14. Estimated completion is 2024-05-08.
What interventions are being tested in trial NCT05579769?
The interventions under investigation include: Cyclophosphamide (DRUG), Mesna (DRUG), Ruxolitinib (DRUG), Cyclosporine (DRUG), Anti-thymocyte globulin (ATG) (DRUG).
Who is sponsoring clinical trial NCT05579769?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.