ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Leland Metheny
Study ID
NCT06680661
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Lymphatic Leukemia
  • Acute Myelogenous Leukemia
  • Chronic Myelogenous Leukemia
  • Chronic Myelomonocytic Leukemia
  • Hodgkin Lymphoma
  • Lymphoma
  • Myelodysplastic Syndrome Other
  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Cyclophosphamide (Cy) is one part of the conditioning regimen. 50 mg/kg beginning on day -6.
  • Fludarabine — DRUG
    Fludarabine (Flu) is one part of the conditioning regimen. 150 mg/m2 (30 mg/m2 per day on days -6 to -2)
  • Thiotepa — DRUG
    Thiotepa (Thio) is one part of the conditioning regimen.10 mg/kg (5 mg/kg per day on days -5 and -4)
  • Total Body Irradiation — RADIATION
    400 cGy (200 cGy per day on days -2 and -1).
  • Double Umbilical Cord Transplant — BIOLOGICAL
    Cord blood is a regulated biologic. Selection of cord blood units will be based on published guidelines.
  • Tacrolimus — DRUG
    Tacrolimus will be administered post transplant. Graft-versus-host disease prophylaxis will consist of tacrolimus and mycophenolate mofetil (MMF), starting on day-5. Tacrolimus will continue at least until day 180 and then be tapered off.
  • Mycophenolate Mofetil — DRUG
    MMF will be administered post transplant. Graft-versus-host disease prophylaxis will consist of tacrolimus and mycophenolate mofetil (MMF), starting on day-5. MMF will continue until day 30.
  • Abatacept — DRUG
    Abatacept at a dose of 10mg/kg will be given on days T-1, T+5, T+14 and T+28.

Study Details

The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT. Participants will: * Partake in exams, tests, and procedures as part of usual cancer care. * Partake in conditioning, which is the treatment that is given before a transplant. * Have a cord blood transplant. * Partake in radiation following the transplant.

Key Dates

Start date
Feb 25, 2025
Status verified
Jun 2025
Primary completion
Oct 29, 2027
Completion
Oct 31, 2028

Study Design

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

Arms

  • Experimental: Cy/Flu/Thio/TBI + dCBT + Tac/MMF + Abatacept
    Cyclophosphamide (Cy), fludarabine (Flu), thiotepa (Thio), and total body irradiation (TBI) is the preparative regimen for Double Umbilical Cord Transplant (dCBT). Graft-versus-host disease prophylaxis will consist of tacrolimus (Tac) and mycophenolate mofetil (MMF). Abatacept will be administered.

Primary Outcome Measure

Severe aGVHD free survival [ Time Frame: 180 days after treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106
Leland Metheny, MD
[email protected]
216-844-0139

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By research site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

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