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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06315309
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Leukemia
  • GVHD,Acute
  • Myelodysplastic Syndromes
  • Myeloproliferative Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • ATG Combined with Tacrolimus and Mini Methotrexate — DRUG
    On Day -7, subjects will be admitted to the hospital and receive a dose of prednisone at 1 mg/kg (ATG premedication). Subjects will receive a steroid injection 3 hours before every ATG infusion. On day -6, subjects will receive a small dose of ATG as an IV infusion. ATG will be repeated on days -5,-4 and -1. Routine transplant chemotherapy agent fludarabine will be given on days -6 to -2 as daily IV infusions. Busulfan, a routine transplant chemotherapy will be given on days -5 to -2 as IV infusion. Subjects with lymphoblastic leukemia will receive an alternative regimen of cyclophosphamide, a routine chemotherapy on days -6 and -5, followed by total body radiation on days -3 to -1. Tacrolimus (standard immune suppression agent) starts on day -3 as continuous IV infusion and switched to oral after engraftment. Methotrexate a standard immune suppression medication which is given IV on day +1,+3,+6, and +11 post-transplant. Blood draws on days -4,-1,+3,+7,+14 to measure ATG levels.

Study Details

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.

Key Dates

Start date
Apr 15, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
29 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 rate of GRFS at one-year post transplant. When accounting for competing risks, any death, relapse, Grade III-IV acute GVHD and cGVHD requiring systemic therapy are competing risks. The reported one year GRFS with the use of standard of care GVHD prevention regimen in MA HSCT (Tac/MTX) was 35%. (El-Jurdi 2023) We hypothesize that with 2 step ATG/Tac/Mini MTX regimen, we can achieve a one year GRFS of 60%.

Primary Outcome Measure

To estimate the therapeutic success of 2-step ATG dosing platform in patients undergoing reduced intensity allogeneic transplantation for treatment of hematologic malignances [ Time Frame: 1 year post transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Zaid S Al Kadhimi, MD (PRINCIPAL_INVESTIGATOR)
Manuel Espinoza-Gutarra, MD (SUB_INVESTIGATOR)
Omer Jamy, MD (SUB_INVESTIGATOR)
Donna Salzman, MD (SUB_INVESTIGATOR)
Razan Mohty, MD (SUB_INVESTIGATOR)
Lauren Shea, MD (SUB_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, AL

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