Who is sponsoring NCT06315309?

NCT06315309 is sponsored by University of Alabama at Birmingham.

What condition does NCT06315309 study?

NCT06315309 studies GVHD,Acute, Acute Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorders.

What drugs are being tested in NCT06315309?

Interventions: ATG Combined with Tacrolimus and Mini Methotrexate.

What is the status of NCT06315309?

NCT06315309 is currently RECRUITING.

Last reviewed 2025-10-06 · How we verify

Phase II Clinical Trial of 2 Step ATG Combined With Tacrolimus and Mini Methotrexate for Prevention of Acute GVHD Post Myeloablative Allogeneic Stem Cell Transplant

NCT06315309 Phase 2 RECRUITING

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.

Details

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 2
Status	RECRUITING
Enrolment	29
Start date	2025-04-15
Completion	2027-05

Conditions

GVHD,Acute
Acute Leukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders

Interventions

ATG Combined with Tacrolimus and Mini Methotrexate

Primary outcomes

To estimate the therapeutic success of 2-step ATG dosing platform in patients undergoing reduced intensity allogeneic transplantation for treatment of hematologic malignances — 1 year post transplant
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.

Countries

United States