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RecruitingPhase 2NCT06680661

ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis

ABBA CORD: Double Umbilical Cord Blood Transplants With Abatacept for Graft Versus Host Disease Prophylaxis

Sponsor

Leland Metheny

Enrollment

20 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

Hodgkin LymphomaLymphomaAcute Myelogenous LeukemiaMyelodysplastic SyndromesChronic Myelomonocytic LeukemiaAcute Lymphatic LeukemiaChronic Myelogenous LeukemiaMyelodysplastic Syndrome Other

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a drug called abatacept (which calms the immune system) to a double umbilical cord blood transplant reduces the risk of graft-versus-host disease (GVHD) — a serious complication where the donor cells attack the patient's body — in people with blood cancers. **You may be eligible if...** - You have a blood cancer such as acute leukemia (AML or ALL), certain lymphomas, myelodysplastic syndrome (MDS), or a similar blood disorder - Your cancer is at high risk or has relapsed, and you need a stem cell transplant - You do not have a fully matched related donor available **You may NOT be eligible if...** - You have uncontrolled cancer at the time of transplant - You have severe organ problems (heart, lung, liver, or kidney) - You have an active, uncontrolled infection - You have a history of prior stem cell transplants in some cases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Cyclophosphamide (Cy) is one part of the conditioning regimen. 50 mg/kg beginning on day -6.

DRUGFludarabine

Fludarabine (Flu) is one part of the conditioning regimen. 150 mg/m2 (30 mg/m2 per day on days -6 to -2)

DRUGThiotepa

Thiotepa (Thio) is one part of the conditioning regimen.10 mg/kg (5 mg/kg per day on days -5 and -4)

RADIATIONTotal Body Irradiation

400 cGy (200 cGy per day on days -2 and -1).

BIOLOGICALDouble Umbilical Cord Transplant

Cord blood is a regulated biologic. Selection of cord blood units will be based on published guidelines.

DRUGTacrolimus

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.

DRUGMycophenolate Mofetil

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.

DRUGAbatacept

Abatacept at a dose of 10mg/kg will be given on days T-1, T+5, T+14 and T+28.

Locations(1)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT06680661

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