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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 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.

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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.

Conditions Studied

Myelodysplastic Syndrome Acute Leukemia Myeloproliferative Disorders

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

FieldValue
Enrollment Target 56 participants
Start Date 2025-04-08
Est. Completion 2028-11
Phase Phase 2

Sponsor

University of Alabama at Birmingham

1,160 total trials

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What the Registry Record Tells You About NCT06265584

The ClinicalTrials.gov registry entry for NCT06265584 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (73% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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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.