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NCT06315309 · ClinicalTrials.gov registry record · Phase 2
Trial of 2 Step ATG for Acute GVHD Prevention Post Myeloablative Allogeneic Stem Cell Transplant
A Phase 2 study of Myelodysplastic Syndromes and Acute Leukemia, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT06315309: Recruiting Phase 2 study of Myelodysplastic Syndromes and Acute Leukemia, sponsored by University of Alabama at Birmingham.
NCT06315309 is a Phase 2 study of Myelodysplastic Syndromes and Acute Leukemia that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 29 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06315309, a Phase 2 study of Myelodysplastic Syndromes and Acute Leukemia, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to test whether the combination of the drugs called tacrolimus (Tac), methotrexate (MTX) and new dosing strategy of another drug called (rabbit Anti-thymocyte Globulin \[ATG\]) will help prevent the development and/or improve severity of acute and/or chronic GVHD.
Primary Outcome
Rate of GRFS (graft versus host disease GVHD, relapse free survival) at one year post transplant. To meet that end point the patient needs to be alive without relapse, or grade III-IV acute GVHD, or chronic GVHD requiring systemic immune suppression.
Conditions Studied
Interventions
- DRUG ATG Combined with Tacrolimus and Mini Methotrexate
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2025-04-15 |
| Est. Completion | 2027-05 |
| Phase | Phase 2 |
What NCT06315309 shows while recruiting
NCT06315309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (90% lower).
The record links to 4 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which ATG Combined with Tacrolimus and Mini Methotrexate is the first listed.
NCT06315309 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT06315309 about?
NCT06315309 is a clinical study titled "Trial of 2 Step ATG for Acute GVHD Prevention Post Myeloablative Allogeneic Stem Cell Transplant". The purpose of this study is to test whether the combination of the drugs called tacrolimus (Tac), methotrexate (MTX) and new dosing strategy of another drug called (rabbit Anti-thymocyte Globulin \[ATG\]) will help prevent the development and/or improve severity of acute and/or chronic GVHD.
What is the current status of trial NCT06315309?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2025-04-15. Estimated completion is 2027-05.
What conditions does trial NCT06315309 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Acute Leukemia, Myeloproliferative Disorders, GVHD,Acute.
What interventions are being tested in trial NCT06315309?
The interventions under investigation include: ATG Combined with Tacrolimus and Mini Methotrexate (DRUG).
Who is sponsoring clinical trial NCT06315309?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06315309 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06315309's enrollment target sits among peer trials
29 124th of 173 higher than 50 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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