Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant

PHASE2RecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

April 8, 2025

Primary Completion Date

August 31, 2028

Study Completion Date

November 30, 2028

Conditions
Acute LeukemiaMyelodysplastic SyndromeMyeloproliferative Disorders
Interventions
DRUG

ATG dosing platform when combined with standard tacrolimus and mini methotrexate

On Day -8, you will be admitted to the hospital and receive a dose of prednisone at 1 mg/kg (ATG premedication). You will receive a steroids 3 hours before every ATG infusion. On day -7, you will receive a small dose of ATG as an intravenous (IV) infusion. ATG will be repeated on days -6, -5 and -1. Routine transplant chemotherapy agent fludarabine will be given on days -7 to -3 as daily IV infusions. Melphalan, another routine transplant chemotherapy will be given on day -4 as IV infusion. Tacrolimus (standard immune suppression agent) will start on day -3 as continuous IV infusion and switched to oral after engraftment. Methotrexate is another standard immune suppression medication which is given IV on day +1, +3, +6, and +11 post-transplant. We plan to draw blood on days -4,, -1, +3, +7, and +14 to measure ATG levels.

Trial Locations (1)

35294

RECRUITING

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
lead

University of Alabama at Birmingham

OTHER