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NCT06265584 · ClinicalTrials.gov registry record · Phase 2
Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant
A Phase 2 study of Myelodysplastic Syndrome and Acute Leukemia, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT06265584: Recruiting Phase 2 study of Myelodysplastic Syndrome and Acute Leukemia, sponsored by University of Alabama at Birmingham.
NCT06265584 is a Phase 2 study of Myelodysplastic Syndrome and Acute Leukemia that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 56 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06265584, a Phase 2 study of Myelodysplastic Syndrome and Acute Leukemia, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
In an effort to reduce graft versus host disease (GVHD) and enhance graft versus leukemia (GVL) effect post allogenic hematopoietic stem cell transplantation (AHSCT), recent research has focused on host immune cell depletion. Frame shifting anti-thymocyte globulin (ATG) backwards to earlier days before days 0 can result in deeper host and less graft T-cell depletion, leading to better immune reconstitution. Preliminary data where 80% of the ATG dose is given on days -6,-5,-4 and 20% given on day -1, showed effective prevention of severe acute GVHD, chronic GVHD and favorable early immune reconstitution. We hypothesize that our 2 step ATG dosing platform when combined with standard tacrolimus and mini methotrexate can prevent grade III-IV acute GVHD and chronic GVHD, resulting in improvement of GVHD/relapse free survival at one year post transplant.
Primary Outcome
Rate of GRFS is defined as the time from date of first dose of fludarabine until occurrence of grade III-IV aGVHD, and or cGVHD requiring systemic immune suppression, and or disease progression or death whichever comes first.
Conditions Studied
Interventions
- DRUG ATG dosing platform when combined with standard tacrolimus and mini methotrexate
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2025-04-08 |
| Est. Completion | 2028-11 |
| Phase | Phase 2 |
What NCT06265584 shows while recruiting
NCT06265584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (73% lower).
The record links to 3 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which ATG dosing platform when combined with standard tacrolimus and mini methotrexate is the first listed.
NCT06265584 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT06265584 about?
NCT06265584 is a clinical study titled "Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant". In an effort to reduce graft versus host disease (GVHD) and enhance graft versus leukemia (GVL) effect post allogenic hematopoietic stem cell transplantation (AHSCT), recent research has focused on host immune cell depletion. Frame shifting anti-thymocyte globulin (ATG) backwards to earlier days bef...
What is the current status of trial NCT06265584?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2025-04-08. Estimated completion is 2028-11.
What conditions does trial NCT06265584 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Acute Leukemia, Myeloproliferative Disorders.
What interventions are being tested in trial NCT06265584?
The interventions under investigation include: ATG dosing platform when combined with standard tacrolimus and mini methotrexate (DRUG).
Who is sponsoring clinical trial NCT06265584?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06265584 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 NCT06265584's enrollment target sits among peer trials
56 59th of 134 higher than 76 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome 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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