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RECRUITING
NCT06680661
PHASE2

ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis

Sponsor: Leland Metheny

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-02-25

Completion Date

2028-10-31

Last Updated

2025-06-04

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

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

DRUG

Fludarabine

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

DRUG

Thiotepa

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

RADIATION

Total Body Irradiation

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

BIOLOGICAL

Double Umbilical Cord Transplant

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

DRUG

Tacrolimus

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.

DRUG

Mycophenolate 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.

DRUG

Abatacept

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