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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06265584
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Leukemia
  • Myelodysplastic Syndrome
  • Myeloproliferative Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ATG dosing platform when combined with standard tacrolimus and mini methotrexate — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 8, 2025
Status verified
Oct 2025
Primary completion
Aug 31, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: phase II single arm study of 2 step ATG dosing in prevention of aGVHD
    The primary outcome for the study is GRFS rate at one-year post transplant. GRFS will be estimated using Kaplan Meier method The reported GRFS with recent phase III trial of PTCY/tac/MMF in transplant from matched related and unrelated donors at 1 year follow up was 52%. We hypothesize that with 2 step ATG/Tac/Mini MTX regimen, we can achieve a one year GRFS of 69%.

Primary Outcome Measure

Rate of GRFS (graft versus host disease GVHD, relapse free survival) at one year post transplant. [ Time Frame: 1 year post transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Zaid Al Kadhimi, MD
[email protected]
(205) 975-1269
Zaid Al Kadhimi, MD (PRINCIPAL_INVESTIGATOR)
Manuel Espinoza-Gutarra, MD (SUB_INVESTIGATOR)
Donna Salzman, MD (SUB_INVESTIGATOR)
Antonio Di Stasi, MD (SUB_INVESTIGATOR)
Lauren Shea, MD (SUB_INVESTIGATOR)
Omar Jamy, MD (SUB_INVESTIGATOR)
Razan Mohty, MD (SUB_INVESTIGATOR)

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